FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 10848619
·
Received November 16, 2020
Report
- Report Number
- 3004753838-2020-137753
- Event Type
- Malfunction
- Date Received
- November 16, 2020
- Date of Event
- October 21, 2020
- Report Date
- November 16, 2020
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000255
- PMA / PMN Number
- DEN170088
- 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
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO ARM, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON OCTOBER 16, 2020. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE POTENTIAL PATIENT MISUSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1309088 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-45 | NI | 00386270000255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |