DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-072912
- Event Type
- Malfunction
- Date Received
- March 28, 2024
- Date of Event
- March 3, 2024
- Report Date
- November 20, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
B5: DESCRIBE EVENT OR PROBLEM - ADDITION INFORMATION/. G3 DATE RECEIVED BY MFG - ADDITION INFORMATION. G6 TYPE OF REPORT - ADDITION INFORMATION. H2: ADDITIONAL INFORMATION/ DEVICE EVALUATION - ADDITION INFORMATION. H6: CONCOMITANT MEDICAL PRODUCTS - ADDITION INFORMATION.
(B)(4).
(B)(4).
(B)(4). 3004753838-2024-072912 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, AN ADDITION IS REQUIRED.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
IT WAS REPORTED THAT A WIRE MISSING 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.
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 |
|---|---|---|---|---|---|---|---|
| 1220950 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9535-45 | 5336126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | ROCHE ACCUCHECK INSIGHT| ROCHE ACCUCHECK INSIGHT |