BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK

    MDR report key: 967871 · Received December 18, 2007

    Report

    Report Number
    MW5004743
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Report Date
    December 18, 2007
    Product Code
    CHH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARDIOCHEK PURCHASED TO DO CHOLESTEROL SCREENINGS AS PART OF A HEALTH SCREENING. WHEN USED AT AN EVENT, THE CHOLESTEROL TOTAL AND HOL TENDED TO BE VERY LOW. SO WE COMPARED 2 CARDIOCHEK MACHINES AGAINST VENIPUNCTURE AND WERE NOT HAPPY WITH RESULTS. REPLACED IT WITH A CHOLESTECH WHICH HAD SIMILAR RESULTS TO VENIPUNCTURE SO HAPPIER WITH RESULTS. DATES OF USE: 2/2007-6/2007. DIAGNOSIS OR REASON FOR USE: CHOLESTEROL SCREENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOCHEK PA ANALYZER CHH

    Patients

    Seq Age Sex Outcome Treatment
    1 YR