BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOBERLINK CONNECT

    MDR report key: 9141057 · Received September 30, 2019

    Report

    Report Number
    MW5090123
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    SOBERLINK HEALTHCARE LLC
    Product Code
    DJZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE BEEN USING THIS DEVICE CALLED "SOBERLINK" THAT'S SUPPOSED TO TEST MY BAC. I SIGNED UP PROACTIVE AS A WAY TO HAVE A "MEASURED" AND DIGITAL COPY OF MY SOBRIETY. IN LESS THAN 30 DAYS, I'VE HAD FOUR FALSE POSITIVE 2 WHEN FIRST WAKING UP, AND 2 LAST NIGHT AFTER BLOWING BUT DOING NOTHING DIFFERENT IN MY DIET / ROUTINE. (ALL TEST RETURN .006-.008, SO FAIRLY MINIMAL). WHEN CONTACTING THE COMPANY, THEY WANT MONEY IN EXCHANGE FOR LOOKING INTO THE ISSUE (FEELS "EXTORTION-Y"). AS SOMEONE WHO DOESN'T DRINK ALCOHOL AND WHO'S CAREFUL ABOUT WHAT'S INGESTED. I'M FINDING THIS DEVICE TO RETURN INACCURATE RESULTS. THE PRODUCT SHOULD BE TESTED BY THE FDA FURTHER. BTW LAST NIGHT IT TESTED ME 3 TIMES, 15 MINS APART, .006, .006, AND .000 RESPECTIVELY. IN THE PAST, I'VE TESTED .008 WHEN FIRST WAKING UP, THEN .000 15 MINS LATER. IN ALL CASES I DID NOTHING. (DIDN'T EAT OR DRINK ANYTHING, NOR RINSE OUT MY MOUTH). THE PRODUCT NEEDS FURTHER TESTINGS, AND THE BUSINESS PRACTICES SHOULD BE REVISED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926950 SOBERLINK CONNECT DEVICES, BREATH TRAPPING, ALCOHOL DJZ SOBERLINK HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR