FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6095857
·
Received November 11, 2016
Report
- Report Number
- 3004753838-2016-51028
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 20, 2016
- Report Date
- October 20, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000125
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND PASSED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747423 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-05 | 5197154 | 00386270000125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |