Dive Brief:
- The Food and Drug Administration posted an early alert Tuesday for a problem with certain Trividia Health blood glucose monitors linked to 114 injuries and one death.
- Earlier this month, Trividia issued a correction for four versions of its True Metrix blood glucose system. The company updated the devices’ instructions for use to clarify that patients should seek medical attention if they have symptoms of high glucose and receive an error code.
- The affected products may issue an error code in the case of a very high blood glucose result (higher than 600 mg/dL) or in the event of a test strip error, according to the FDA alert.
Dive Insight:
The FDA uses early alerts to inform the public of potentially high risk device issues. Trividia updated the instructions for its blood glucose meters because they could lead to a delay in treatment if users don’t seek medical attention when they receive an E-5 error code and have symptoms of high blood glucose, such as fatigue, thirst or blurry vision.
Delaying treatment could have serious health consequences for people with very high blood glucose levels, including dehydration, altered mental status or death, according to the early alert.
The correction applies to all True Metrix branded blood glucose meters distributed in the U.S., Mexico, the U.K., Australia and the Caribbean. It also affects co-branded products sold in pharmacies including CVS, Kroger and Walgreens, according to Trividia’s letter to customers. The injuries and deaths were reported since August 2014, when Trividia first launched the devices. The injuries and death reports are as of Jan. 16, according to the FDA.
The True Metrix devices don’t need to be returned or replaced, and patients may continue to use them, according to the alert.
Trividia recalled some of its True Metrix monitors last year over concerns that some of the devices may have defective LCD displays.
