FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 6030254
·
Received October 14, 2016
Report
- Report Number
- 3004753838-2016-84582
- Event Type
- Malfunction
- Date Received
- October 14, 2016
- Date of Event
- September 16, 2016
- Report Date
- September 19, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000163
- 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).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE COMPLAINT RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED DATA LOG FOUND FIRMWARE ERRORS. THE REPORTED EVENT THAT THE RECEIVER CEASED TO FUNCTION WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681394 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22495-PNK | 5210037 | 00386270000163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |