San Diego-based Dexcom is conducting a Class 1 recall of glucose monitoring system receivers because of an alarm failure.
The CGM systems include a below-the-skin sensor that measures blood glucose readings, which are sent to a hand-held receiver. However, the audible alarm in the G4 Platinum and G5 Mobile CGM system may not be activated in the receiver when the system detects low or high glucose levels, according to the notice.
As a result, diabetes patients who rely on the system to alert them to low or high blood sugar could see serious adverse effects, including death.
Dexcom sent out notifications Feb. 23, informing customers of the problem. According to the company, it had received complaints about the speaker component failing to provide audible alerts and alarms.
However, William Blair analysts reviewed the FDA’s MAUDE database and found several dozen patient reports about the issue over the past few months. They failed to find any instances of patient harm.
Further, they don’t think it will have a major financial impact. The analysts note it is a quality issue; however, company management has not detailed how it plans to resolve the problems.
According to the analysts, Dexcom “is not planning to proactively replace the handhelds in the field,” and is simply notifying patients to test their devices periodically. “We believe it has been working with its supplier to resolve the issue and is replacing the defective devices when they fail,” they write, adding that management “must have concluded that the rate and risk are both extremely low and manageable with this limited response.”
The company did not respond to a request for comment by press time.
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