DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-336676
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- November 27, 2024
- Report Date
- March 4, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002518
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). B5: DESCRIBE EVENT OR PROBLEM ¿ CORRECTION G3: DATE RECEIVED BY MANUFACTURER - ADDITIONAL H2: ADDITIONAL INFORMATION - CORRECTION.
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.
THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND THE AUDIO TEST FAILED. AN ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO AN ASSEMBLY ERROR; IT WAS NOTED THE SPEAKER INSTALLED TILTED. PICTURES WERE TAKEN. THE SPEAKER AND VIBRATOR RESISTANCES WERE MEASURED AND PASSED. THE PERFORMANCE DATA WAS REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED AS NO AUDIO OUTPUT. THE PROBABLE CAUSE WAS DETERMINED TO BE ASSEMBLY ERROR VIA PRODUCT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT NO ALERT/NOTIFICATION OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED ANDECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TEST PASSED RELEVANT TESTS AND FAILED IN SERIAL NUMBER VERIFICATION TEST. AN ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO FOREIGN OBJECT DAMAGE TO SPEAKER/FOD. THE SPEAKER/VIBRATOR RESISTANCE WAS MEASURED AND PASSED. RECEIVER SPEAKER/SOUND MANUAL TEST WAS PERFORMED AND FAILED DUE TO LOW SOUND. THE PERFORMANCE DATA WAS EVALUATED. THE ALLEGATION WAS CONFIRMED AS NO AUDIO OUTPUT. THE PROBABLE CAUSE OF NO AUDIO OUTPUT COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76727 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 18038136 | 00386270002518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Female |