Tandem Diabetes Care has issued an urgent medical device correction for its Tandem Mobi insulin pump after a software defect was found to prevent the pump from delivering insulin properly.
Tandem first notified users of the issue back in October, urging them to update their software and stay alert for problems. The company advised anyone who received a Malfunction 12 alert to silence the alarm, contact support, switch to a backup insulin delivery method, and monitor their blood sugar closely. According to Tandem, the pump may fail to recognize a motor issue, which can cause it to stop delivering insulin or lose communication with the CGM entirely.
This week, the FDA escalated the matter to a Class I recall, the most serious category, citing the risk of serious injury or death.
Tandem Mobi malfunction 12 alert (Source: Tandem Diabetes Care).
Tandem Mobi is the smallest tubed insulin pump on the market in the U.S. It measures 2.5 inches tall, and less than half the size of the t:slim X2. The pump holds up to 200 units of insulin and is powered by Control-IQ+ technology, which predicts glucose levels 30 minutes ahead and adjusts basal insulin every five minutes. It also features a bolus button, wireless recharging, and compatibility with the Dexcom G6 and Dexcom G7 continuous glucose monitors (CGMs).
This is not the first insulin pump recall of the year. The FDA previously issued a Class II recall for MiniMed insulin pumps, and Omnipod issued a medical device correction for its Omnipod 5.
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