FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 18783240
·
Received February 26, 2024
Report
- Report Number
- 3004753838-2024-047089
- Event Type
- Malfunction
- Date Received
- February 26, 2024
- Date of Event
- January 19, 2024
- Report Date
- February 26, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002808
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT UNSPECIFIED WEARABLE ISSUE OCCURRED FOR THE TRANSMITTER WITH THE SERIAL NUMBER (B)(6). HOWEVER, DATA FOR THE TRANSMITTER WITH THE SERIAL NUMBER (B)(6) WAS PROVIDED FOR EVALUATION. THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS OVER ONW HOUR WAS FOUND. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS DUE TO THE TRANSMITTER AND APP NOT BEING ABLE TO ESTABLISH A CONNECTION. THE REPORTED EVENT OF UNSPECIFIED WEARABLE ISSUE IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS OVER ONW HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1920702 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-151 | 1523039775 | 00386270002808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female |