FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 18587662
·
Received January 26, 2024
Report
- Report Number
- 3004753838-2024-023377
- Event Type
- Malfunction
- Date Received
- January 26, 2024
- Date of Event
- January 3, 2024
- Report Date
- February 14, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2024-023377 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS AVAILABLE. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1121064 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |