Catalog Number STT-GF-001 |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/08/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Dexcom was made aware on (b)(4) 2018 that the display device showed a transmitter failed error on (b)(6) 2018.No product or data was provided for evaluation.The complaint confirmation of a transmitter failed error could not be determined.A probable cause could not be determined.No additional patient or event information is available.
|
|
Manufacturer Narrative
|
Com-(b)(4). .
|
|
Event Description
|
The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Voltage testing was performed and resulted in 0 voltage.There was no data log available to confirm the reported event of a failed transmitter error.The complaint confirmation was unable to be determined.A probable cause could not be determined.No additional patient or event.
|
|
Search Alerts/Recalls
|