FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3841863
·
Received May 30, 2014
Report
- Report Number
- 3004753838-2014-09366
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 4, 2014
- Report Date
- May 4, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED HARDWARE ERROR CODE ON THE RECEIVER.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED A HARDWARE FAILURE. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO RESTART DEVICE ON (B)(6) 2014. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THEIR DEVICE TO BE INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318989 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 | 5102253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |