When you see headlines about a diabetes product recall and realize that your medical device might be impacted, panic can set in. Now what?

In light of recent product safety news about Medtronic insulin pumps and Insulet’s Omnipod DASH system, (see details below), we started thinking about the chain of events that follows the headlines:

  • What if customers are concerned about continuing to use the product?
  • Is the company communicating clearly and providing adequate customer service?
  • Do health insurance companies care if a product they cover or recommend is presenting possible dangers?
  • How do doctors and diabetes care specialists respond to patients with concerns?

All of this hit home recently for Paul Dobbertin, a longtime type 1 in the Chicago suburbs who became concerned about his Medtronic insulin pump after seeing a swarm of media coverage following the recent FDA warning about a product recall. He phoned the company and fought to get a replacement device, despite customer service downplaying the situation and insisting his unit didn’t need replacing.

“We are right to be concerned,” he says. “Managing all the details of a system along with type 1 diabetes is a lot of work and expensive already, without the added worry of faulty equipment and a known problem.”

First, don’t get confused by the varying language used in these situations. The word “recall” doesn’t always mean that you must return a product. There are also “correction” notifications, “market removals,” and other related labels. See this guide to FDA definitions of the various cases.

The FDA explains that most recalls are “voluntary actions” carried out by manufacturers and distributors as part of their responsibility to protect public health when certain products may present a risk of injury or are otherwise defective.

In most cases, only certain batches (specific models or SKU numbers) of products are impacted. So most often, it’s a case-by-case evaluation of whether a return is warranted on a specific unit, if the problem in question applies.

Here are specifics on the latest diabetes recalls announced in early 2020:

The Minimed 600 series of devices are impacted by a tiny part on the top of the pump called the retainer ring, which is supposed to keep the insulin reservoir secure inside the pump. A malfunction can cause it to crack or come loose, interfering with insulin delivery and possibly leading to a user receiving more or less insulin than they’re supposed to. It wouldn’t lead to an emptying of the reservoir, Medtronic tells us, but could cause an insulin delivery delay or a faster, unscheduled bolus different than what was expected.

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Image: Medtronic Diabetes

Medtronic originally issued an urgent safety notification about this issue on Nov. 21, 2019, and notified the FDA about it. At that time, the company was already working on an action plan with regulators about addressing those potentially faulty parts of the device.

Importantly, it’s not uncommon for a manufacturer to issue a safety alert or notification and then for the FDA to issue a recall classification a few months later. That’s what happened here, with the FDA issuing a Class 1 recall on Feb. 12, 2020, designating this as the most serious type of device recall they issue.

How many devices are impacted?

A total of 322,005 devices are impacted, including:

  • all lots of the Minimed 630G pumps distributed from September 2016 to October 2019
  • all lots of the 670G Hybrid Closed Loop system distributed between June 2017 and August 2019

Any injuries or deaths?

Per the FDA report based on company data, Medtronic received 26,421 complaints about this particular retainer ring malfunction since those insulin pump batches were distributed. Included in that data are 2,175 “injuries” and one possible death related to this issue.

Yikes! is a first response when seeing those figures. But while concerning, Medtronic emphasizes that the data can be misleading if taken out of context. Of the total 2,175 incidents labelled “injuries” that included high or low glucose events, 94 percent (2,045 total) were “self-remedied by the patient and required no medical intervention.” Regarding the one death reported, there is no conclusive evidence that it was related to a loose, damaged, or missing retainer ring. But it also can’t be ruled out.

In our previous in-depth coverage of product recalls, DiabetesMine talked with FDA insiders and company officials who urged caution about looking at recall numbers in the proper context — especially since the FDA’s database of “adverse events” is far from perfect.

“You can’t just look at the number of recalls and make conclusions based on those numbers alone. You have to take into context what the recall was, how it was found, and what else was going on with the company at the time. That’s hard to do from the outside, because you don’t have those conversations and context all the time,” cautions Dr. Courtney Lias, director of the FDA’s division of chemistry and toxicology devices.

Meanwhile, our D-Community has been saturated with Medtronic safety alerts in recent months: from the FDA’s alert in mid-November about older insulin pumps and cybersecurity, to news reports about a federal lawsuit filed in reference to a Florida woman who had died 2 years earlier as a possible byproduct of using a Minimed 530G system that had a recall tied to a possibly faulty infusion site.

Within a day of the Medtronic 600 series recall announcement, Insulet issued a medical device correction alert about the tubeless Omnipod DASH patch pump and its personal diabetes manager (PDM) used to control the system. Described as a precautionary measure, the notification says there’s a remote possibility that the PDM “may suggest an insulin bolus amount based on incorrect information” and that could result in too much or too little insulin being delivered.

Specifically, the issue involves the bolus calculator feature used in figuring out food and correction doses based on a current blood glucose (BG) value and the user’s insulin on board (IOB). Normally, the PDM prevents a reading older than 10 minutes to be used in calculations. But with this glitch, older data is being pulled.

The problem is specific to software versions 1.0.50 and earlier (see the About menu on the PDM to figure out which version you have).

At the time of the alert, 11 complaints had come in about this issue and no injuries were reported, according to Insulet. And this doesn’t mean you can’t use the DASH PDM — just that you should take extra care to make sure a current BG value is entered when using the bolus calculator.

Per the alert, a software update is being developed to fix the issue that is slated to become available in March 2020. New PDMs with the fix will be shipped out to affected customers, and the company says it will contact those customers when it’s time to ship.

Naturally, despite these reassurances, people with diabetes (PWDs) may have lingering questions and concerns.

Paul Dobbertin

Dobbertin in Illinois, for one, had been using a Minimed insulin pump since the mid-1990s and had been on the 670G for a couple of years. While he wasn’t completely happy with its ease of use overall, quality assurance didn’t become a pressing concern for him until November 2019.

Despite receiving a Medtronic safety alert and being reassured by the company that all was OK, Dobbertin started worrying that his 670G device might be impacted after seeing the latest news on the FDA recall notice.

He phoned Medtronic’s customer service for more information. A pre-recorded message detailed the recall and he filled out a form online. He took off the pump and put it in a drawer, turning to multiple daily injections (MDI) as needed. After a full day of waiting without any response, he called back to reach customer service about what he’d seen reported.

“(The rep) described most of the news being reported as incorrect and said the pump wasn’t actually recalled,” Dobbertin told DiabetesMine. “This just confused me more. The news online — CNN, NBC, BBC, and even the FDA — all seemed to be stating otherwise. I know news gets twisted, but the fact that so many had been reported injures was terrifying.”

Although his pump part in question looked intact, Dobbertin didn’t want to risk it. His vision isn’t great, and he was concerned about having to keep a close eye on the device because it could break at any time — especially since his warranty had already expired. He’s had severe low blood sugar insulin reactions before, where he’s awoken to see paramedics standing over him, and he didn’t want to experience that again.

“I expressed that I just wouldn’t live with the fear of accidentally overdosing myself with a massive amount of insulin, as had (possibly) already happened to someone, because of a known flaw,” he said.

Despite initial reluctance to replace the pump, a supervisor eventually OK’d sending a replacement device within a few days. Dobbertin is pleased with the service he received in handling his case, even though his 670G didn’t appear to be impacted by this issue.

He’s not alone, as Medtronic is getting inundated with hundreds of calls in just the early days of the recall news. PWDs sharing their experiences online are expressing mixed feelings about the seriousness of this particular recall, with some noting it’s “no big deal” and others expressing major concern.

Wanda Labrador and her son, Justice

D-Mom Wanda Labrador in Rochester, New York, says her family was impacted by this latest Medtronic recall, but luckily they had stopped using it even before the company issued the urgent safety notification last fall.

Labrador’s son Justice was diagnosed at 3 years old on Thanksgiving Day 2012, and that following summer he started using a blue Minimed insulin pump. Eventually, after long awaiting the promise of closed loop technology, Justice started on the 670G pump in July 2018.

But within a couple months, Wanda says she noticed the retainer ring would often come loose, and she’d need to tighten it regularly. That continued until it eventually became worn and chipped, and on Christmas Eve 2018 she called Medtronic to report the damage. They received a replacement pump the next day (Merry Christmas?). However, 5 months later, she says the same thing happened again; the retainer ring came off and disappeared.

Many others in device chat groups online were reporting similar issues and saying they had called the company about it — sometimes getting a replacement, but often hearing customer service reps express surprise and then and being told it wasn’t anything to worry about.

“I felt like something was wrong with the pump, even though Medtronic never sent me a warning about the danger of having a loose or missing ring,” she says. “There were times when the entire reservoir would just slide out… that wasn’t OK!”

Concerned, but also to take a break from pump therapy itself, Justice stopped using the 670G and went back on injections during the summer months. He eventually went to diabetes camp and learned about the Omnipod and Dexcom, and despite still having an in-warranty Medtronic pump, their insurance approved the new devices. Despite that, Labrador is still technically an in-warranty Medtronic customer but has not received any letter or notification about this retainer ring malfunction.

“When I saw the media coverage, I felt lucky to have dodged a bullet and that my son was never harmed,” she says. “At the same time, I was upset that it took so long for the public to find out about the possible harm that the issue can cause. People’s lives are at stake and it’s not fair that the pumps were not recalled earlier. They must do better.”

Big insurers like Anthem and Blue Cross Blue Shield tell us they do take recall information into consideration. But none of the insurers DiabetesMine spoke with in the week following these latest diabetes recalls indicated they had actual data available on how often safety issues are raised, or how their institution might use that info in making coverage decisions.

With Medtronic’s “preferred brand deal” with UnitedHealthcare (UHC) that limits member access to non-Medtronic diabetes devices, some have wondered if UHC is taking notice of this Class I recall of its preferred brand.

UHC’s Communications Director Tracey Lempner says Medtronic notified the insurer in 2019 about this issue impacting the Minimed 600 series of insulin pumps.

UHC then issued a statement to impacted members that read: “The safety of our members is a priority, and we encourage anyone who may have questions or concerns about their insulin pump to consult with their doctor and contact Medtronic for more information. We will continue to work closely with Medtronic as well as monitor the latest clinical evidence to make sure our members with diabetes have continued access to safe, affordable care.”

We would be curious to see any data about how often people raise product recall issues in their coverage requests and appeals, and what insurers do about that overall.

Also curious about how doctors and diabetes care specialists might handle patients’ concerns about product safety issues, we reached out to several to ask what they might advise to someone facing those worries. The theme is pretty consistent: It’s case-by-case, depending on the particular product or medication and issue involved. Often, physicians will reach out to the company directly for more info and any recourse needed.

“We try to be proactive and see if it really is a danger that our patients would be affected by,” said Dr. Jennifer Dyer, a pediatric endocrinologist in Ohio.

“We are pretty patient with (these problems) as we know they are machines and can be unreliable at times, so we always teach our patients to be smarter than the machines. In our practice, we have an extremely thorough program based on that principle, so thankfully our patients are generally OK when these things happen. In this most recent case, our patients should be fine following our protocols,” she explains.

In Texas, endocrinologist and diabetes author Dr. Stephen Ponder says he also discusses any recalls with patients and lets them decide how to proceed. Sometimes, they’ll want to contact a company about a specific concern, whereas at other times patients are confident they don’t have a malfunctioning device and are happy to keep using it.

“In my experience, recalls are simply a part of life,” he said. “I don’t know if we are rushing products to market too soon or not. We do have a more sophisticated user base in diabetes now than any time in history and that user base is interconnected through social media. That allows product problems to reverberate with greater and more rapid intensity than in the 70s, 80s, or 90s.”