DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2026-092330
- Event Type
- Malfunction
- Date Received
- February 17, 2026
- Date of Event
- February 10, 2026
- Report Date
- April 9, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004109
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). 3004753838-2026-092330 WAS REPORTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4). B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION D9 DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION D9 DATE DEVICE RETURNED - ADDITIONAL INFORMATION G3 DATE RECEIVED BY MFG - ADDITIONAL INFORMATION G6 TYPE OF REPORT - UPDATED/FOLLOW-UP H2 TYPE OF FOLLOW UP - ADDITIONAL INFORMATION.
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.
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 2/26/2026. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202
PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS BEING REVIEWED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE REVIEW IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429924 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825251010 | 00386270004109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male |