FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3870855
·
Received June 12, 2014
Report
- Report Number
- 3004753838-2014-04750
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 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 INTERMITTENT AUDIO OUTPUT.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED INTERMITTENT AUDIO OUTPUT (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, AT THE TIME OF THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO TEST ALERT FUNCTIONALITY AND PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 347666 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 | 5118238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |