BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELO GLUCOSE BIOSENSOR SYSTEM

    MDR report key: 21936669 · Received April 30, 2025

    Report

    Report Number
    3004753838-2025-102616
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 2, 2025
    Report Date
    November 12, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    SAF
    PMA / PMN Number
    K234070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-102616 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. PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS BEING REVIEWED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE REVIEW IS COMPLETE.

    Description of Event or Problem · 0

    AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 4/15/2025, IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369628 STELO GLUCOSE BIOSENSOR SYSTEM CONTINUOUS GLUCOSE MONITOR SAF DEXCOM, INC. 9500-174 1724280003

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female