BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCOTEST 7110 MKIII-C

    MDR report key: 2232210 · Received August 26, 2011

    Report

    Report Number
    MW5021926
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    February 5, 2010
    Report Date
    August 26, 2011
    Manufacturer
    DRAEGER SAFETY DIAGNOSTIC
    Product Code
    DJZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I WAS ARRESTED FOR DWI IN THE TOWNSHIP OF (B)(6) IN THE STATE OF (B)(6). I WAS DIRECTED TO BLOW INTO A DRAEGER ALCOTEST 7110 MKIII-C. THE SERIAL NUMBER WAS (B)(4). THE DEVICE REPORTED A LONG BLOWING TIME THAT I DID NOT BELIEVE THAT I COULD PRODUCE. MY SUSPICIONS WERE CONFIRMED BY A PULMONOLOGIST, DR (B)(6), M.D. IT IS MY UNDERSTANDING THAT OTHERS DEFENDANTS HAVE PRODUCED LONGER BLOWING TIMES INCONSISTENT WITH NORMAL HUMAN FUNCTION. THE DEVICE IS DESIGNED SO THAT IT IS NEVER CALIBRATED FOR THE PULMONARY FUNCTIONS THAT IT REPORTS. THE LITER VOLUME, BLOWING TIME, AND PRESSURE AND FLOW SENSORS ARE NOT ROUTINELY CALIBRATED. IN ADDITION, THE MFR HAS FAILED TO COMPLY WITH 21 CFR PART 820. THEY FAILED TO SUBMIT A 510K. THEY FAILED TO REGISTER THEIR PRODUCTION FACILITIES. THEY CHANGED THEIR SOFTWARE WITHOUT FDA APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCOTEST 7110 MKIII-C NONE DJZ DRAEGER SAFETY DIAGNOSTIC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other