FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5774842
·
Received July 7, 2016
Report
- Report Number
- 3004753838-2016-34805
- Event Type
- Malfunction
- Date Received
- July 7, 2016
- Date of Event
- March 9, 2016
- Report Date
- March 9, 2013
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000231
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Description of Event or Problem · 0
PATIENT CONTACTED DEXCOM ON 03/09/2016 TO REPORT THAT THE RECEIVER DISPLAYED ERR121 ON 03/09/2016. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431571 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | DEXCOM, INC. | MT22719 | 5205015 | 00386270000231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |