FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3895516
·
Received June 25, 2014
Report
- Report Number
- 3004753838-2014-04848
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- March 4, 2014
- Report Date
- June 2, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE CONFIRMED NO AUDIO OUTPUT.
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED NO AUDIBLE ALERTS. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369938 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 | 5091252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other |