BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOBERLINK CONNECT

    MDR report key: 21111478 · Received January 8, 2025

    Report

    Report Number
    MW5164455
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    January 5, 2025
    Report Date
    January 6, 2025
    Manufacturer
    SOBERLINK HEALTHCARE LLC.
    Product Code
    DJZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SOBERLINK DEVICE GAVE A FALSE POSITIVE READING, RESULTING IN MY PARENTING TIME BEING TAKEN AWAY PENDING COURT ACTION. WAS TESTED ON A SECONDARY DEVICE AND IT SHOWED A NEGATIVE TEST, ALSO CONTACTED LOCAL LAW ENFORCEMENT AND THE TEST WITH THEM WAS ALSO NEGATIVE. TEST WAS REPEATED ON BOTH MACHINES, SOBERLINKS DEVICE KEPT REPORTING POSITIVE WHILE THE SECONDARY MACHINE WAS NEGATIVE. NON-SMOKER. REF REPORT: MW5164454.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422537 SOBERLINK CONNECT DEVICES, BREATH TRAPPING, ALCOHOL DJZ SOBERLINK HEALTHCARE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other BUPROPION.| BUSPIRONE. | FLUOXETINE.