FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 5495981
·
Received March 11, 2016
Report
- Report Number
- 3004753838-2016-05506
- Event Type
- Malfunction
- Date Received
- March 11, 2016
- Date of Event
- January 8, 2016
- Report Date
- January 8, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000163
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Description of Event or Problem · 0
PATIENT CONTACTED DEXCOM ON 01/08/2016 TO CLAIM NO AUDIO OUTPUT ON 01/08/2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152606 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | MDS | DEXCOM, INC. | MT22495-PNK | 5204319 | 00386270000163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |