DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2019-65673
- Event Type
- Malfunction
- Date Received
- September 12, 2019
- Date of Event
- August 14, 2019
- Report Date
- February 18, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
(B)(4).
AN INTERNAL VISUAL INSPECTION REVEALED FOREIGN OBJECT DAMAGE ON THE SPEAKER DUST COVER. THE CUSTOMER'S COMPLAINT OF LOW AUDIO OUTPUT WAS CONFIRMED WITH A ROOT CAUSE DETERMINED TO BE FOREIGN OBJECT DAMAGE.
(B)(4).
(B)(4).
THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND PASSED. THE RECEIVER WAS CHARGED AND REBOOTED. THE RECEIVER LOGS PASSED. THE LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERRORS RELATED TO THE COMPLAINT. A RECEIVER FUNCTIONAL TEST WAS PERFORMED AND IT FAILED SPEAKER TESTS. A GLOBAL COMMUNICATION TOOL TONE AT MEDIUM TEST WAS PERFORMED AND IT FAILED SOUND TESTS. "TRY IT" MANUAL FUNCTIONAL TESTS WERE PERFORMED AND THE TESTS FAILED. THE RECEIVER CASE WAS OPENED FOR AN INTERNAL VISUAL INSPECTION AND IT FAILED DUE TO FOD FOUND INSIDE THE SPEAKER DIAPHRAM. THE SPEAKER RESISTANCE WAS MEASURED AND IT REGISTERED WITHIN SPECIFICATION. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE IS FOD.
IT WAS REPORTED THAT THE RECEIVER HAD LOW AUDIO OUTPUT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796122 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | MT24078-1 | 5253193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |