FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 24866230
·
Received April 13, 2026
Report
- Report Number
- 3004753838-2026-130247
- Event Type
- Malfunction
- Date Received
- April 13, 2026
- Date of Event
- April 3, 2026
- Report Date
- April 13, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004765
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2026-130247 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 5/13/2028 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT A DETACHED NEEDLE OR CANNULA OCCURRED. NO RELEVANT PRODUCT OR DATA RELATED TO THE ISSUE WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT IS UNDETERMINED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925424 | DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9510-003 | 1726038003 | 00386270004765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male |