DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2026-053225
- Event Type
- Malfunction
- Date Received
- January 17, 2026
- Date of Event
- January 8, 2026
- Report Date
- March 16, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004116
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2026-053225 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2026. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO SERIOUS OR PROLONGED PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED.
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED.
SUBSEQUENT TO THE INITIAL MDR SUBMISSION, PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(6) 2026 FOR THE APPLICATOR AND ON (B)(6) 2026 FOR THE G7 WEARABLE. AFTER FURTHER REVIEW, THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166892 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825234004 | 00386270004116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | INSULIN PUMP. |