DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-231647
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Date of Event
- August 16, 2024
- Report Date
- April 16, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K231081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). MFR NO 3004753838-2024-231647 AND 3004753838-2024-231647-01 WERE REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. 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.
IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566385 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 2524064001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |