Regulatory Focus™ > News Articles > Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month

Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month

Posted 15 April 2013 | By

Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary recall for all its blood glucose meter devices, citing the same core defect that led to last month's recall of a similar product manufactured by Johnson & Johnson.


On 25 March 2013, Lifescan, a subsidiary of Johnson and Johnson, issued a recall of nearly 2 million of its OneTouch Verio IQ blood glucose meters, citing the potential for the device to malfunction at a critical time.

"The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE," Lifescan wrote in its recall notice. The company said it had sent an Urgent Medical Device Voluntary Recall letter in March 2013 to "all affected customers" indicating that they should discontinue distribution of the product.

Lifescan added another 710,413 units to that recall on 12 April 2013, bringing the total units affected up to around 3,000,000.

Another Device Joins the Fray

Now medical device manufacturer Abbott has issued a similar warning regarding its FreeStyle InsuLinx blood glucose meter line of products, citing an identical error to the one identified by LifeScan.

"At rare, extremely high blood glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading," Abbott wrote in a notice.

Compare that notice to Lifescan's, issued on 25 March 2013: "LifeScan is recalling and replacing all OneTouch Verio IQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment."

Though both companies explained that such readings are "very rare," they represent serious health risks to a patient in the event that they do occur, potentially leading to serious injury or death if the condition is not immediately corrected. Abbott said it was only aware of a single patient having been injured in such a circumstance, and that it was unclear if its FreeStyle InsuLinx product was the direct cause of that injury.

Unlike Lifescan, however, Abbott indicated that patients could correct what it called a software problem using an update available on its website. Lifescan had issued a physical recall of its products, indicating that replacement units would be sent to all patients.

Abbott customers may also return the units for a replacement product.

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