Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the smart device displayed an error message for low transmitter battery.Data was provided for evaluation.Data review could not confirm the reported event of low transmitter battery.A probable cause could not be determined post investigation.This complaint is reportable based on the finding of permanent loss of connection.No product was provided for evaluation.No additional patient or event information is available.
|
Dexcom was made aware on 07/20/2018, that on (b)(6) 2018, the smart device displayed an error message for low transmitter battery.Data was provided for evaluation.Data review could not confirm the reported event of low transmitter battery.Additionally; the transmitter has been received for evaluation.An external visual inspection was performed and the passed.A voltage test was performed and the transmitter passed as it had voltage.Review of the log data was performed and permanent loss of connection was observed.The reported issue of low transmitter battery was not confirmed via product testing.This complaint is reportable based on the finding of permanent loss of connection via log data review.A probable cause could not be determined post investigation.No additional patient or event information is available.
|