DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-203678
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Date of Event
- July 24, 2024
- Report Date
- December 16, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). ¿B5: DESCRIBE EVENT OR PROBLEM ¿ ADDITIONAL INFORMATION. ¿D9: DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION. ¿D9: DATE DEVICE RETURNED - ADDITIONAL INFORMATION. ¿H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION. ¿H3: DEVICE EVALUATED BY MFG- ADDITIONAL INFORMATION.
(B)(4).
(B)(4) WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE. 3004753838-2024-203678-01. 3004753838-2024-203678-02.
IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. 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.
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. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2350504 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1724096002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male |