DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-071427
- Event Type
- Malfunction
- Date Received
- March 26, 2025
- Date of Event
- February 27, 2025
- Report Date
- August 15, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000866
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2025-071427 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. H2: CORRECTION.
IT WAS REPORTED THAT A DETACHED NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. 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.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION ADDITION IS REQUIRED. IT WAS REPORTED THAT A DETACHED NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6)2025. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 3/20/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1048524 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9535-77 | 7356645 | 00386270000866 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Male | HUMALOG KWIK PEN.| LANTUS. |