We’ve been pressing for more detail from Abbott Diabetes Care since mid-last-week about its latest batch of recalls, impacting a huge number of customers using FreeStyle test strips and meters — including ALL OmniPod users.

If you haven’t heard yet, check out our initial NewsFlash about the recall of their test strips and older FreeStyle and FreeStyle Flash blood glucose meters.

news release on the Abbott Diabetes press room page details the issue and has includes recommendations from Kelly Duffy, VP of Quality Assurance and Compliance:

Recently, it has come to our attention that FreeStyle Blood Glucose Test Strips may produce erroneously low blood glucose results when using the FreeStyle blood glucose meter built into the OmniPod Insulin Management System. Erroneously low blood glucose results that are not recognized may pose significant risks to your health.

In a second related recall, the same is apparently true for the FreeStyle Flash and older FreeStyle blood glucose meters (both of which are no longer made), i.e. they “may produce erroneously low blood glucose results when using FreeStyle Lite and FreeStyle blood glucose test strips.”  

What we learned from Insulet is that newer models of Abbott glucose meters apparently have the capability to “eliminate the noise” caused by the faulty test strips. But FreeStyle meter models developed earlier — including the meter in the OmniPod (older and newer) system — do not. This is why Abbott is issuing two separate recalls; from their side, it’s easier to simply upgrade customers to a newer meter model, but since the OmniPod has the meter built-in, the solution there is to replace customers’ current stores of test strips.

What should you do if you use any of these? Abbott is recommending that you discontinue use of the effected strips and meters immediately, and call for replacements:

For the OmniPod Personal Diabetes Manager (PDM) to receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159*.

We’re being told they’ll replace up to 400 strips immediately, and more can be replaced later once they have more supplies stocked up. Customers are being asked to provide the following information: test strip info (lot numbers and expiration), the pharmacy you get your test strips from (phone and location), your insurance info, and the phone and address of your doctor.

*Note: we’ve been trying to get through on that line for several days; the telephone queue line is quite long!

* UPDATED 2/27: Customer Service tells us that the only FreeStyle strips safe to use with Pods are Lot #s 1376759 & 1371831, or those expiring after August 2015.

For the FreeStyle Flash or FreeStyle meters — call Abbott Diabetes Care Customer Service at 1-888-345-5364 to have Abbott send you a new FreeStyle-branded meter at no charge.

Dual letters from Abbott and Insulet were sent out via Priority Overnight FedEx service to all their customers in the last few days, which was both overdue and undoubtedly quite costly. (Note that the FedEx envelope Amy received was marked “earthsmart carbon neutral”):

The letters are pretty generic, however, and don’t say much more than what’s on the Abbott website.

What surprised us most is the slow burn of getting this information out online, especially in light of our recent post and community discussion about the best way to handle communication around recalls.

And despite numerous efforts to get answers, we’ve been frustrated that Abbott Diabetes hasn’t aired more detail behind this big recall, even days after they did publish a basic notice on their website.

It appears that the current recall is actually an expansion of an Abbott recall that began with 20 lots in late November 2013, and has been under investigation for almost three months now.  Abbott Diabetes Care apparently let the FDA know in late January that it had decided to expand the initial recall. From there, it took some weeks to get through all the official channels until word would reach the people actually impacted.

All the while, people using these strips and meters were none the wiser that the supplies and devices they were using may be producing false low readings. Not good, Abbott.

Here’s a timeline, as we’ve been able to ascertain:

  • Late November 2013 – Abbott Diabetes issued a voluntary recall that included 20 lots of strips.
  • Late January 2014 – this is when the company notified the FDA about the decision to expand that recall to include all FreeStyle strips being used by OmniPod customers.
  • Feb. 19, 2014 – two “recall letters” were posted in Abbott Diabetes Care’s online “press room,” letting the world know about these potential problems — or at least those who might happen upon that web page.
  • Friday, Feb. 21-Monday, Feb. 24 – no other customer notification occurred, unless you knew to call customer service yourself. Wait times on the phone line were more than an hour. Many pharmacies and doctors were still clueless about the recalls, according to countless anecdotes from PWDs posted online.
  • Monday, Feb. 24 – many people received the overnight FedEx letters from Abbott, which included their own informational letter as well as Insulet’s. Oddly, the Abbott letter is dated Feb. 14, indicating that it was prepared even earlier than we thought but received by customers at least 10 days later.

Hmm, it’s also worth pointing out that the Nov. 27 recall was posted on the corporate Abbott news page, while this latter expanded recall impacting even more customers was not, and appeared only on the Abbott Diabetes Care press room page. Even though technically, these weren’t “press releases” but customer notification letters.

This isn’t the first recall of its kind for Abbott Diabetes. Back in 2010, Abbott pulled 359 million test strips from the market in the U.S. and Puerto Rico after discovering a similar problem with erroneous low blood sugar readings. And last spring, Abbott’s diabetes device business recalled FreeStyle InsuLinx meters that were giving people inaccurately high glucose readings.

We were in touch with Abbott’s public affairs manager Jessica Sachariason, who was only able to provide a tiny bit of additional information on this latest recall on behalf of the company, as follows:

DM) What is the exact nature of the problem, making the strips and meters produce the “erroneously low readings”?

ADC) The root cause has been determined to be a strip manufacturing process error, which only expresses when a strip is used with a non-applied voltage meter (FreeStyle, FreeStyle Flash, and the FreeStyle meter built into the Omnipod system).  The manufacturing error causes a decreased response in the system glucose readings. Meters with applied voltage are not impacted and do not express a decreased response in the system glucose readings.

Have adverse events been reported?

There have been Medical Device Reports (MDRs) filed with the FDA, which are potentially associated with this issue. Abbott is investigating these reports.

What has Abbott done to resolve this issue in the manufacturing or quality control process, to ensure it doesn’t happen again? 

Abbott has implemented additional quality control processes.

What total amount of strips and meters, or more importantly people, are impacted by the recalls?

The user base of the FreeStyle Flash Blood Glucose Monitoring system and FreeStyle Blood Glucose Monitoring systems represents approximately 1% of our U.S. customer base that use Abbott’s FreeStyle meters.

{Editor’s note: Most companies keep their customer numbers as a closely guarded secret, although it’s common in recalls to see an actual number of how many products are being recalled.}

When did you find out about this?

Following the conclusion of the investigation linked to the November recall, Abbott determined that in the interest of patient safety to expand the recall.  Abbott proactively contacted the FDA and promptly initiated a product recall in affected markets and has communicated with all affected parties.

How did you arrive at the number of 400 strips to initially replace for each customer?

The health and safety of our patients is our highest priority. Approximately 99 percent of the U.S. customer base who use Abbott’s FreeStyle family of meters are not impacted as they do not use FreeStyle Flash or FreeStyle Blood Glucose Meter systems. After a thorough evaluation of customer testing needs and consulting with stakeholders, 400 test strips should replace a customer’s inventory of test strips and provide an initial two to three month supply to the customers. This amount should cover the customer until the customer’s next visit to the pharmacy to replenish their next test strip supply. Due to these factors, there is no action required by doctors, pharmacies, and suppliers. If an HCP, pharmacy or supplier has a question, they should contact Abbott’s diabetes care customer service and a representative will provide support.

Why are people being asked to provide doctor/insurance information on the customer service call?

Customers are being asked to provide doctor/insurance information in order to determine the most appropriate route for future strip replacements.

Although Abbott wasn’t able to elaborate on anything relating to adverse events when we asked, a quick search through the FDA’s database shows a number of reports involving potential issues with FreeStyle strips and meters relating to these recalls. Reading through a few of the summaries is very unnerving. Especially frightening was one adverse event report we found from December, in which a physician reported that it’s possible an OmniPod-using PWD may have died from ketoacidosis as a result of these falsely low BG readings from the built-in meter!

All of these recall troubles combined, with the whole botched handling of the Freestyle Navigator CGM discontinuation in 2009 and 2010 is enough to really shake customers’ faith in Abbott Diabetes Care.

We know that product recalls happen, as sure as acts of God. What’s key in this day and age is the need for swift action and transparency by the manufacturers.