FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3931644
·
Received July 14, 2014
Report
- Report Number
- 3004753838-2014-04962
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 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).
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE DATA LOG DID NOT CONFIRM THE REPORTED INTERMITTENT AUDIO OUTPUT.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014, TO CLAIM NO AUDIO OUTPUT ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411080 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |