Model Number MT20649-1 |
Device Problem
Defective Alarm (1014)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/28/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermediate audio output.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of no audio output could not be determined.A root cause could not be determined.
|
|
Manufacturer Narrative
|
(b)(4).Describe event or problem - correction "dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermediate audio output.The complaint confirmation of no audio output could not be determined.".
|
|
Event Description
|
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the receiver had intermittent audio output.The complaint confirmation of intermittent audio output could not be determined.
|
|
Search Alerts/Recalls
|