Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the receiver operates only when connected to the charger.No additional patient or event information is available.The complaint device was returned for evaluation.The device was visually inspected and no defect was found.The receiver log was reviewed and screen error alarms and firmware errors were observed.The reported event of receiver operates only when connected to charger was confirmed during log review.A root cause could not be determined.
|