FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 23011454
·
Received September 9, 2025
Report
- Report Number
- 3004753838-2025-252175
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- August 13, 2025
- Report Date
- December 1, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002198
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-252175 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).
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. CUSTOMER ADVOCACY. COMPLAINT IS NOT REPORTABLE PER CORPFT-140202
Description of Event or Problem · 0
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. NO PRODUCT OR DATA 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
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2803396 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1824310006 | 00386270002198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | UNKNOWN PUMP OR PEN. |