FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 23960859
·
Received January 5, 2026
Report
- Report Number
- 3004753838-2026-003470
- Event Type
- Malfunction
- Date Received
- January 5, 2026
- Date of Event
- December 19, 2025
- Report Date
- March 17, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004116
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2026-003470 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. 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.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR SUBMISSION, PRODUCT WAS RECEIVED FOR EVALUATION ON 2/17/2026 FOR THE APPLICATOR AND ON 2/26/2026 FOR THE G7 WEARABLE. AFTER FURTHER REVIEW, THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE PER CORPFT-140202.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18863 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825190008 | 00386270004116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |