Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver ceased to function.No additional event or patient information is available.The receiver was returned for evaluation.An external visual inspection was performed and passed.A receiver charge and boot was performed and failed due to receiver not turning on.The receiver case was opened, and an internal visual inspection was performed and failed due to a damaged battery.A receiver download was performed and rtt loss was observed.The battery was replaced with a known good battery to retrieve the receiver download.Confirmation of the complaint was confirmed.The probable cause was a damaged receiver battery.
|