FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4903493
·
Received July 9, 2015
Report
- Report Number
- 3004753838-2015-23082
- Event Type
- Malfunction
- Date Received
- July 9, 2015
- Date of Event
- June 15, 2015
- Report Date
- June 15, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS ATTEMPTED BUT WAS NOT COMPLETED DUE TO THE ERROR MESSAGED DISPLAYED ON THE RECEIVER SCREEN. THE RECEIVER WAS UNABLE TO COMMUNICATE WITH THE GLOBAL COMMUNICATION TOOL. THE REPORTED EVENT OF A HARDWARE ERROR WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 AND CLAIMED THAT ON (B)(6) 2015 THE PATIENT EXPERIENCED A HARDWARE FAILURE. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445961 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-PNK | 5179433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |