DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-130382
- Event Type
- Malfunction
- Date Received
- June 1, 2024
- Date of Event
- February 20, 2024
- Report Date
- March 3, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003584
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). B3 DATE OF EVENT - CORRECTION . B5: DESCRIBE EVENT OR PROBLEM ¿ CORRECTION. H2 TYPE OF FOLLOW UP - CORRECTION.
(B)(4).
(B)(4). MFR 3004753838-2024-130382 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE UPPER BUTTOCKS ON (B)(6) 2024 AND THE OVERLAY PATCH NOT USED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, AN EARLY SENSOR EXPIRATION WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE TRANSMITTER FAILURE 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 |
|---|---|---|---|---|---|---|---|
| 2319552 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-160 | 1723248001 | 00386270003584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Male |