FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3881519
·
Received June 18, 2014
Report
- Report Number
- 3004753838-2014-09602
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- February 19, 2014
- Report Date
- May 28, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, PATIENT EXPERIENCED A HARDWARE FAILURE. INTERNATIONAL DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT. DEXCOM ISSUED AN RGA FOR THE PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357861 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-1 | 5050543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |