DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-200695
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- July 14, 2024
- Report Date
- October 31, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001788
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
.(B)(4). 3004753838-2024-200695 AND 3004753838-2024-200695-01 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 OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. PERFORM VOLTAGE TEST WAS PERFORMED AND FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND PASSED. PERFORMANCE DATA WAS REVIEWED/ NOT PROVIDED FOR EVALUATION. THE ALLEGATION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED AS THE ALLEGATION WAS NOT FOUND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. 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 |
|---|---|---|---|---|---|---|---|
| 2275358 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 18038763 | 00386270001788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female |