DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-013554
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 29, 2024
- Report Date
- May 12, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K231081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-013554 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4).
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024 . PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS BEING REVIEWED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE REVIEW IS COMPLETE.
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 511225 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1724268004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female |