FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6116787
·
Received November 21, 2016
Report
- Report Number
- 3004753838-2016-52301
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Date of Event
- October 31, 2016
- Report Date
- October 31, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
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, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE TRANSMITTER WAS RETURNED FOR EVALUATION. EXTERNAL VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO OBSERVATIONS FOUND RELATED TO THE CUSTOMER COMPLAINT. A PAIRING TEST WITH THE NORDIC BLUETOOTH DEVICE WAS PERFORMED AND PASSED AS IT WAS POSSIBLE TO DOWNLOAD THE TRANSMITTER LOG DURING THE TEST. THE GLOBAL TRANSMITTER FINAL FUNCTIONAL TEST WAS PERFORMED AND PASSED WITH NO DEFICIENCY. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE REPRODUCED WITH THE TRANSMITTER AND THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767920 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-06 | 5214209 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |