FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7241440
·
Received February 5, 2018
Report
- Report Number
- 3004753838-2018-012284
- Event Type
- Malfunction
- Date Received
- February 5, 2018
- Date of Event
- December 15, 2017
- Report Date
- January 7, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000293
- 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). THE PATIENT EXPERIENCED A PRODUCT PROBLEM ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180107-000155.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 01/07/2018 THAT ON (B)(6) 2017 A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW DID NOT CONFIRM THE REPORTED EVENT OF A LOSS OF CONNECTION. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84730 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | N/A | 00386270000293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |