BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOLESTRAK

    MDR report key: 695597 · Received March 17, 2006

    Report

    Report Number
    MW1038311
    Event Type
    Injury
    Date Received
    March 17, 2006
    Report Date
    March 17, 2006
    Manufacturer
    ACCUTECH LLC
    Product Code
    NFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE TEST KIT REPACKAGED BY ACCUTECH LLC AS CHOLESTRAK -AND OTHER REPACKAGERS- HAS BEEN GIVING ERRORNEOUS RESULTS FOR THE PAST 2 YEARS. SINCE HEART DISEASE IS THE NUMBER ONE KILLER OF AMERICANS AND SINCE THE RESULTS ARE ALWAYS AT LEAST 40 POINTS TOO LOW, I AM REPORTING THIS AS A LIFE-THREATENING SITUATION FOR ALL THOSE WHO USE THIS PRODUCT AND BELIEVE THE RESULTS BASED ON THE FDA APPROVAL OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTRAK * NFX ACCUTECH LLC * 05P0476
    2 INSTANT CHOLESTEROL TEST * NFX HOME ACCESS HEALTH CORP. * 04P0404

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening