FDA Adverse Event
Malfunction
Summary report: N
STELO GLUCOSE BIOSENSOR SYSTEM
MDR report key: 22159086
·
Received June 6, 2025
Report
- Report Number
- 3004753838-2025-143015
- Event Type
- Malfunction
- Date Received
- June 6, 2025
- Date of Event
- May 12, 2025
- Report Date
- August 29, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- UDI-DI
- 00386270004338
- PMA / PMN Number
- K234070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-143015 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM 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.
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 5/19/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619727 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1725084001 | 00386270004338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Unknown |