FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3971461
·
Received July 31, 2014
Report
- Report Number
- 3004753838-2014-25124
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- May 24, 2014
- Report Date
- July 7, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM NO AUDIO OUTPUT ON (B)(6 )2014, RESULTING IN A HYPOGLYCEMIC EVENT. PATIENT CLAIMS BEING DISCOVERED UNCONSCIOUS BY HER CHILDREN IN PATIENT'S BEDROOM. AN AMBULANCE WAS CALLED. PATIENT RELAYED BEING HOSPITALIZED FOR TWO (2) DAYS AND TWO (2) NIGHTS, WHERE PATIENT WAS TREATED WITH GLUCAGON AND GIVEN SEVERAL INFUSIONS. NO FURTHER INTERVENTION OR OTHER INJURIES WERE REPORTED AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT. PATIENT REPORTED TO DEXCOM TECHNICAL SUPPORT A CURRENT CONDITION OF FEELING WELL AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447129 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |