FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 21939589
·
Received April 30, 2025
Report
- Report Number
- 3004753838-2025-103309
- Event Type
- Malfunction
- Date Received
- April 30, 2025
- Date of Event
- April 3, 2025
- Report Date
- September 18, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003935
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-103309 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 4/30/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO ABDOMEN WHICH IS OFF LABEL USAGE OF THE DEVICE, 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 |
|---|---|---|---|---|---|---|---|
| 188917 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1824330004 | 00386270003935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |