Catalog Number STT-GF-001 |
Device Problems
Use of Device Problem (1670); Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/23/2018 |
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.The device has been received for investigation.A follow-up will be submitted upon completion of device investigation.No additional patient or event information is available.
|
|
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.The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Voltage testing was performed, and the test failed.A review of the downloaded data log did not confirm the reported event of failed transmitter error.A probable cause could not be determined.No additional patient or event information is available.
|
|
Search Alerts/Recalls
|