FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3932654
·
Received July 14, 2014
Report
- Report Number
- 3004753838-2014-09772
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 14, 2014
- Report Date
- June 16, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM A HARDWARE ERROR ON (B)(6) 2014, RESULTED IN A HYPOGLYCEMIC EVENT. PATIENT CLAIMS WAKING UP FROM A HYPOGLYCEMIC EVENT IN HIS HOME AND REPORTED A FRIEND CONTACTED 911. WHEN THE AMBULANCE ARRIVED, PATIENT RELAYED THE RESPONDERS ADMINISTERED TWO TUBES OF GLUCOSE GEL, THEN TRANSPORTED PATIENT TO THE EMERGENCY ROOM. PATIENT DID CLAIM TO DEXCOM TECHNICAL SUPPORT AN ATTEMPT RESET THE DEVICE, BUT THE ERRORS CONTINUED. PATIENT REPORTED CURRENT CONDITION TO DEXCOM TECHNICAL SUPPORT AT AWAKE AND ALERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409746 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |