There's very little information available on what happens to patients out in the real world when a diabetes device gets recalled. Today, in Part 2 of our current series on FDA Recalls, we share one such story, and the fallout. {Please check out Part 1 of our series here.}

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D-Mom Polina Bryson remembers when her 9-year-old daughter started seeing numbers on her Abbott FreeStyle meter that didn’t seem right.

The blood sugar results were low, but that didn’t jibe with how her daughter was feeling at the time. And those numbers didn’t match up with what their trusty Dexcom continuous glucose monitor was displaying, either.

This was in early 2014, about a year after Polina’s daughter was diagnosed with type 1 diabetes. She was using the OmniPod tubeless insulin pump and the integrated Abbott FreeStyle glucose meter that went with it, and they had been depending on the glucose readings from that meter to make dosing decisions.

Luckily, when these surprisng low readings began to appear, they had the CGM as an extra layer of security and enough sense to check the girl’s blood sugar on a different meter. That indicated the results were off, and certainly not numbers they should be using to dose insulin and calibrate the CGM.

Soon, Polina learned from media reports and via the Diabetes Online Community that the Abbott FreeStyle test strips they’d been using were at fault: a Class 1 recall had been issued by the manufacturer and FDA.

Thousands of affected FreeStyle meters and strips were being recalled by Abbott (the actual number was never revealed, but it was supposed to be 1% of Abbott's customer base), and Polina realized this was more than just some “fluke lows” on her end. According to the FDA, mistakes could result in "serious injury or even death," and Polina knew she needed to take immediate action to get replacement strips for her daughter.

That’s when the troubles truly began for Polina and many customers trying to deal with this product recall.

Polina says she couldn’t get basic questions answered about the recall, wasn’t able to get safe replacement strips for her daughter in a timely manner, and experienced an overall failure from Abbott in fixing the problem.  She literally spent hours on hold on their customer support line -- and then more time explaining her needs to multiple people who didn’t seem to be clear on what was going on. After these calls, there was a lack of follow-up. Meanwhile, Polina's daughter had to carry and use a different meter in addition to their PDM, and there were delays in getting the necessary test strips.

While Polina describes this as "an inconvenience," the only reason it wasn’t disastrous is because of the backup D-tech the family had on hand. She realizes that others may not have been so fortunate -- especially those who may be newly diagnosed or not have a backup meter or access to a CGM. For those people, reacting to these false lows could cause a real calamity.

“Still, the hassle and headache were pretty bad,” she says. “Abbott really botched the process in the beginning. They were severely understaffed and unprepared to handle the call volume generated by the recall. It was very frustrating. Perhaps our ‘mistake’ was to get on it right away and try to resolve it ASAP.”

As luck would have it, right before hearing about this Abbott recall, Polina had ordered a whole new batch of test strips -- to the tune of 800 affected strips. So theoretically she needed replacements for that entire amount. As it turns out, getting replacements for any proved to be a near impossible task...

Several weeks after hearing about the recall and phoning Abbott multiple times, Polina says her family received a certified FedEx letter about the recall -- a little late for her since she had already learned about it online. But this can be a problem in itself for customers, who may not be home to sign for the letter. Polina just happened to have a child home sick so she was on hand to sign on the second day FedEx came by her house.

She read the letter and immediately tried calling the dedicated hotline set up for recall. That led to an hour-long hold and eventually she was disconnected, unable to get through to anyone again. After many attempts over several days, she finally got through.

But then Abbott told her they could only replace half of her newly ordered strips -- just 400 out of 800 -- at once. Reluctantly, she agreed. Better than nothing, she thought. But days went by and nothing arrived. Even though Abbott insisted the strips were en route, and repeated that claim, Polina says they received nothing after days upon days of waiting and making follow-up phone calls.

Representatives kept telling Polina they’d call back with answers, but that didn’t happen.

All the while, the family was buying new strips at the local pharmacy out of pocket in order to use a backup glucose meter.

Eventually, after throwing a “little tantrum” over the phone, Polina says they were assigned a specific person to handle their case instead of dealing with random customer service reps who had no access to previous notes and no answers to their questions. Apparently, the half-order of strips they’d ordered previously vanished into thin air; no one seemed to know what happened to it, even though company records showed that it was shipped.

“Eventually they re-ship and we get our order. What was supposed to be a one-day thing turned into a process that took a couple of weeks and a ton of our time and energy,” she says, noting that this can be a real hardship for busy working parents trying to juggle the demands of life and caring for a diabetic child.

After all was said and done, Polina said she filed an official complaint with Abbott about the recall response. She received no company feedback after that. Eventually, she received those 400 replacement strips as promised, but that’s about all the closure the Bryson family would get.

Abbott has one of the highest numbers of recalls and largest amount of products pulled from the market, according to the FDA database of recall records going back to late 2002. While the numbers alone don’t necessarily indicate misdeeds on the part of a device maker, recalls often bring out the faults in company communication processes as they try to effectively and quickly communicate with customers when troubles arise.

We know from our previous research that product recalls aren't always life-threatening emergencies. Sometimes it's just a matter of a glitch in the labeling that prompts FDA to request that a company pull a batch of products from market. But the fact is, these recalls have real and immediate consequences on people living with diabetes and their families. That's why a swift and efficient response is so important. This goes far beyond brand loyalty and "making the customer happy" to serious quality of life issues for the customer affected.

Unfortunately, as we see here, not all companies have the proper plans in place to take care of their customers. The Abbott FreeStyle strip recalls in 2013 and 2014 are examples of that, as they brought a chorus of complaints -- despite Abbott's similar experience with a 2010 recall stemming from false lows.

Just like Polina and her family, many in the D-Community said the real problem wasn’t the faulty strips or the recall itself. Rather, the trouble came in the aftermath of trying to get answers and a resolution from the manufacturer.

For their part, Abbott did respond when queried, but unfortunately only with a prepared statement that doesn't offer any specifics about their past recalls or policies:

“At Abbott, the health and safety of patients is our highest priority. Across all of our businesses, Abbott works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients,” wrote Jessica Sachariason in media relations at Abbott Diabetes Care.

Polina and others in the community can only hope that in the case of a future recall, Abbott and peers have a better plan in place to respond to customers quickly and above all, efficiently. And even though this case was far from life-endangering, sometimes there's a fine line between inconvenience and throwing a real monkey wrench into patients' glucose control, as they await vital replacement supplies.

“I realize that as to impact, we didn’t have any dire results,” Polina says. “We are lucky. I understand not everyone was as fortunate as we were.”

 

Next up: Part 3 of our series on FDA Recalls, addressing how problems with diabetes devices can sometimes turn into litigation.