FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 20340252
·
Received September 30, 2024
Report
- Report Number
- 3004753838-2024-251923
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Date of Event
- August 29, 2024
- Report Date
- April 9, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003584
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). MFR 3004753838-2024-251923 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
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT A DETACHED NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON (B)(6) 2024. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41673 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-160 | 1723307001 | 00386270003584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |