DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-022325
- Event Type
- Malfunction
- Date Received
- January 27, 2025
- Date of Event
- December 23, 2024
- Report Date
- March 25, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001900
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). MFR 3004753838-2025-022325-01 WAS REPORTED IN ERROR. PLEASE DISREGARD H6 CODE 4121, AS THE EVENT LOG WAS NOT DOWNLOADED FOR REVIEW.
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL D9: DEVICE AVAILABILITY - ADDITIONAL H2: ADDITIONAL INFORMATION/DEVICE EVALUATION H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL. H6: ADVERSE EVENT PROBLEM - ADDITIONAL.
(B)(4). D9: DEVICE AVAILABILITY - CORRECTION. H2: CORRECTION. THE D9 ON MFR (3004753838-2025-022325-01) WAS REPORTED IN ERROR. PLEASE DISREGARD THE DEVICE AVAILABLE FOR EVALUATION DATE ON THAT SUBMISSION, AS THIS INFORMATION WAS CORRECTLY INCLUDED IN THE INITIAL.
(B)(4).
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGE TEST WAS NOT PERFORMED DUE TO THE POWER DROPPING OUT WHEN CONNECTED TO CHARGER OR DOWNLOAD TOOL. A RECEIVER BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TESTS WERE NOT PERFORMED DUE TO THE POWER DROPPING OUT WHEN CONNECTED TO CHARGER OR DOWNLOAD TOOL. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS NOT DOWNLOADED FOR REVIEW DUE TO THE RECEIVER NOT TURNING ON. AN ERROR ICON WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, AN UNEXPECTED RECEIVER SHUTDOWN WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE UNEXPECTED RECEIVER SHUTDOWN COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 771875 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 17306071 | 00386270001900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male |