FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6146602
·
Received December 5, 2016
Report
- Report Number
- 3004753838-2016-56671
- Event Type
- Malfunction
- Date Received
- December 5, 2016
- Date of Event
- November 2, 2016
- Report Date
- November 8, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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, LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED. THE TRANSMITTER WAS RETURNED FOR EVALUATION. EXTERNAL VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO OBSERVATIONS FOUND RELATED TO THE CUSTOMER COMPLAINT. A TRANSMITTER VOLTAGE TEST WAS PERFORMED AND IT FAILED. THE UNIT SHOWED NO VOLTAGE. LOG REVIEW SHOWED SIGNAL LOSS ON ISSUE DATE. THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED . THE ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795859 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-06 | 5212281 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | UNKNOWN SMART PHONE |