LifeScan Updates: Animas Vibe with Dexcom integration submitted to FDA; meters recalled
The first quarter of 2013 has been eventful for Johnson & Johnson Diabetes Care. Animas Corporation submitted the Animas Vibe insulin pump to the FDA, integrated with the Dexcom G4 Platinum. This Animas Vibe will display Dexcom CGM data right on the pump screen, alleviating the need for Vibe users to carry the G4 Platinum receiver. If the review process goes smoothly, the integrated device might be approved by the end of 2013. As we covered in diaTribe #52, LifeScan also recently received FDA clearance for the OneTouch VerioSync, which sends blood glucose data directly to an iPhone app.
In less positive news, LifeScan recalled the OneTouch Verio IQ (worldwide), OneTouch Verio Pro (Europe), and OneTouch Verio Pro+ (hospitals outside the US) in late March because the meters had problems notifying users of very high blood glucose readings. Normally, the meters display “Extreme High Glucose” when a test indicates blood sugars above 600 mg/dl. However, because of a software problem, the meters respond incorrectly to extreme glucose values above 1,024 mg/dl – the VerioIQ shuts down and enters set-up mode, the Verio Pro displays and stores an incorrect low result, and the Verio Pro+ stores an incorrect result. Though such glucose levels are very rare, people who use these meters should follow LifeScan’s instructions for replacement meters, which it is providing for free. According to LifeScan, if users have not received their replacement meters yet, they may continue to test with their OneTouch VerioIQ meters while they wait for their replacement meters to arrive as long as they are aware of this issue. For more information, see www.onetouch.com or read this PDF. –MN/AB