Abbott Laboratories recently notified customers that a safety risk has been identified for specific versions of its FreeStyle Libre glucose monitoring sensors. In fact, this issue has contributed to at least seven known deaths around the world. The warning is aimed at FreeStyle Libre 3 sensors. These sensors are model 72080-01 and UDIs 00357599818005 and 00357599819002. In particular, the alert draws attention to the FreeStyle Libre 3 Plus sensors. These sensors are sold under model numbers 78768-01 and 78769-01, associated with UDIs 00357599844011 and 00357599843014.
This precarious state of affairs impacts nearly three million of the same sensor in the United States, all built from one production line. Abbott’s notice points out that almost half of these devices either have expired or have been used up by patients already. As of November 14, the firm acknowledged a running total of 736 serious adverse events associated with these sensors. Later, they had to reassure us that no one died on American soil.
Abbott has reacted to these shocking reports by acting decisively. To remedy this, they’ve started a process by which those bugged can petition for replacements of their compromised sensors. The company invites users to check if their devices are affected by going to www.FreeStyleCheck.com. In addition, Abbott officials pointed to how dire the crisis is in a statement issued last week.
“These decisions may pose serious health risks, including potential injury or death.” – FDA
The majority of safety events reported occurred internationally. During the press conference, the FDA orthodoxy has been adamant that immediate action is not warranted on the bad products. In light of these developments, Abbott is taking steps to ensure that customers are informed and supported through the replacement process.
The company has consistently contended that safety is still its top concern, and has reiterated its desire to find a solution quickly. Abbott’s FreeStyle Libre product line aims to make diabetes management easier with continuous glucose monitoring functions. Yet, even amid these recent worries, the core realization that condition of product and end consumer safety are paramount to a successful medical device should be reiterated.
