DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-141294
- Event Type
- Malfunction
- Date Received
- June 13, 2024
- Date of Event
- January 14, 2024
- Report Date
- June 26, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002808
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). 3004753838-2024-141294 AND 3004753838-2024-141294-01 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL AND SUPPLEMENTAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED DUE TO NO DAMAGE. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. A REVIEW OF THE DATA LOGS WAS PERFORMED AND A PAIRING FAILURE WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. 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.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1124031 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-151 | 1523061900 | 00386270002808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female |