DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-100991
- Event Type
- Malfunction
- Date Received
- April 29, 2025
- Date of Event
- March 27, 2025
- Report Date
- June 9, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002518
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). .
(B)(4).
(B)(4). H2: ADDITIONAL INFORMATION: MFR (3004753838-2025-100991) WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1427887 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 17526951 | 00386270002518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |