DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-074134
- Event Type
- Malfunction
- Date Received
- March 29, 2024
- Date of Event
- February 4, 2024
- Report Date
- May 16, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002525
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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.
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGE WAS PERFORMED AND PASSED. A RECEIVER BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND FAILED DUE TO FAILED SERIAL NUMBER VERIFICATION. ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED DUE TO LOW SOUND. SPEAKER/VIBRATOR RESISTANCE MEASURED WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO FOREIGN OBJECT DAMAGE TO SPEAKER/FOD. THE PERFORMANCE DATA WAS REVIEWED FINDING ERRORS RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED AS LOW AUDIO OUTPUT VIA PRODUCT. THE PROBABLE CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER VIA PRODUCT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2582881 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | MT26403-0 | P16494903 | 00386270002525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male |