DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-192788
- Event Type
- Malfunction
- Date Received
- July 22, 2025
- Date of Event
- July 8, 2025
- Report Date
- September 11, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003935
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-192788 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4). A4: WEIGHT- CORRECTION. B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D9: DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION. D9: DATE DEVICE RETURNED - ADDITIONAL INFORMATION. H2: TYPE OF FOLLOW UP - ADDITIONAL INFORMATION/ CORRECTION. H6: ADDITIONAL INFORMATION.
(B)(4).
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 7/19/2025, AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6)2025. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2037227 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825064004 | 00386270003935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female |