DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2026-091243
- Event Type
- Malfunction
- Date Received
- February 13, 2026
- Date of Event
- February 8, 2026
- Report Date
- April 23, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004109
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2026-091243 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 DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.
PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 3/19/2026 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206782 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825162003 | 00386270004109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male |