FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7217852
·
Received January 24, 2018
Report
- Report Number
- 3004753838-2018-008916
- Event Type
- Malfunction
- Date Received
- January 24, 2018
- Date of Event
- December 26, 2017
- Report Date
- February 6, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 10386270000238
- 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). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 171226-001733.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60683 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | MT22719 | 5225805 | 10386270000238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |