FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 20036861
·
Received August 22, 2024
Report
- Report Number
- 3004753838-2024-210924
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- July 19, 2024
- Report Date
- September 21, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). MDR 3004753838-2024-210924 WAS REPORTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
UPDATING MDR DUE TO BEING SELECTED AS REPORTABLE IN ERROR PER CUSTOMER ADVOCACY. COMPLAINT IS NOT REPORTABLE PER (B)(4).
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940277 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male |