DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-223570
- Event Type
- Malfunction
- Date Received
- September 4, 2024
- Date of Event
- August 7, 2024
- Report Date
- June 27, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2024-223570 AND 3004753838-2024-223570-01 AND 3004753838-2024-223570-02 AND 3004753838-2024-223570-03 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL AND SUPPLEMENTAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3: DEVICE EVALUATED BY MFG - ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION.
PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS BEING REVIEWED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE REVIEW IS COMPLETE.
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. PERFORMANCE DATA WAS REVIEWED. SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A TRANSMITTER FAILURE 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.
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.
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. PERFORMANCE DATA WAS REVIEWED. SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, A TRANSMITTER FAILURE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711315 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1724039001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |