STELO GLUCOSE BIOSENSOR SYSTEM
Report
- Report Number
- 3004753838-2025-012751
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 22, 2024
- Report Date
- May 12, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- PMA / PMN Number
- K234070
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2025-012751 AND 3004753838-2025-012751-01 WERE REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTINGS OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED.
PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
SUBSEQUENT TO THE INITIAL MDRS, IT WAS DETERMINED THAT REPORTS WERE SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1274341 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1724135004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male |