DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-122308
- Event Type
- Malfunction
- Date Received
- May 22, 2024
- Date of Event
- April 30, 2024
- Report Date
- June 27, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). PRODUCT REGISTRATION - CORRECTION. B5: DESCRIBE EVENT OR PROBLEM ¿ SUBSEQUENT TO INITIAL MDR. D4: CATALOG NO - CORRECTION. G3: DATE RECEIVED BY MANUFACTURER - ADDITIONAL. H2: ADDITIONAL INFORMATION/CORRECTION. H10: CORRECTED DATA.
(B)(4).
(B)(4).
(B)(4). 3004753838-2024-122308, 3004753838-2024-122308-01, AND 3004753838-2024-02 WERE REPORTED IN ERROR. PLEASE DISREGARD INITIAL AND SUPPLEMENTAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
SUBSEQUENT TO INITIAL MDR, A CORRECTION IS REQUIRED.
IT WAS REPORTED THAT THE READINGS FROZE. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS MISUSE OF THE DEVICE. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT THE READINGS FROZE. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. 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 |
|---|---|---|---|---|---|---|---|
| 1596596 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1523317001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |