FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 19968726
·
Received August 12, 2024
Report
- Report Number
- 3004753838-2024-201621
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- July 17, 2024
- Report Date
- September 9, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4) UPDATING MDR DUE TO COMPLAINT CLASSIFICATION CODE CHANGE. COMPLAINT IS NOT REPORTABLE PER CORPFT-140202
Description of Event or Problem · 0
IT WAS REPORTED THAT A DEXCOM APP CRASH OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 0
UPDATING MDR DUE TO NON-REPORTABLE MISUSE. COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2174389 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Female |