FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7972005
·
Received October 16, 2018
Report
- Report Number
- 3004753838-2018-124772
- Event Type
- Malfunction
- Date Received
- October 16, 2018
- Date of Event
- August 22, 2018
- Report Date
- August 22, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
SR-(B)(4). MODEL #/CATALOG #/LOT #/UDI # - CORRECTION "9438-05, STT-GL-004, 6005944, (B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THE SMART DEVICE DISPLAYED AN ERROR MESSAGE FOR LOW TRANSMITTER BATTERY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR INVESTIGATION. DATA INVESTIGATION CONFIRMED A LOW TRANSMITTER BATTERY IN ADDITION, A FAILED TRANSMITTER ERROR WAS PRESENT IN CONNECTION TO THE REPORTED ALLEGATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED ISSUE OF LOW TRANSMITTER BATTERY IS REPORTABLE BASED ON THE FINDING OF A FAILED TRANSMITTER ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 810487 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 6005998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |