DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2023-191561
- Event Type
- Malfunction
- Date Received
- September 21, 2023
- Date of Event
- August 22, 2023
- Report Date
- December 13, 2023
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001900
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2023-191561 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4).
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.
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. PERFORM VOLTAGE TEST WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1585999 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | P16149067 | 00386270001900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |