FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3771635
·
Received April 24, 2014
Report
- Report Number
- 3004753838-2014-04494
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 25, 2014
- Report Date
- March 30, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED NO AUDIO OUTPUT.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, PATIENT EXPERIENCED NO AUDIO OUTPUT WHEN BLOOD SUGAR READING WENT BELOW THE LOW ALERT THRESHOLD. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN HER DEVICE TO BE INVESTIGATED. PATIENT DID NOT REPORT 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 |
|---|---|---|---|---|---|---|---|
| 249539 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |