Dexcom announced a recall of the Continuous Glucose Monitoring Systems due to the possibility of the audible alarm not activating in the receiver piece when hypoglycemia or hyperglycemia is detected.
Patients who depend on this product for notification of low or high blood glucose levels could experience serious adverse consequences, including death, if the auditory alarm does not sound to alert the patient.
- Dexcom has recalled all model numbers and Lot numbers of the following:
- Dexcom G4 PLATINUM Receiver
- Dexcom G4 PLATINUM (Pediatric) Receive
- Dexcom G4 PLATINUM (Professional) Receiver
- Dexcom G4 PLATINUM Receiver with Share
- Dexcom G4 PLATINUM (Pediatric) Receiver with Share
- Dexcom G5 Mobile Receiver
The affected products were manufactured between July 29,2011 to March 10, 2016 and were distributed between October 22, 2012 to March 10, 2016. A total of 263,520 units have been recalled nationally.
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In February 2016, the Company sent a Customer Notification Letter with the following instructions to test and verify the audio alert on the receiver. Users should contact Dexcom at any time if the audio alert is malfunctioning. Healthcare professionals should report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information call (844) 607-8398 or visit FDA.gov