BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXON-TREND

    MDR report key: 160307 · Received March 27, 1998

    Report

    Report Number
    160307
    Event Type
    Malfunction
    Date Received
    March 27, 1998
    Report Date
    March 27, 1998
    Manufacturer
    ALEXON-TREND
    Product Code
    MHJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC ASSAY FOR CRYPTOSPORIDIUM INFECTION IS PRODUCING FALSE-POSITIVE RESULTS. RESULTED IN REPORTING ABOUT 40 PTS WITH FALSE-POSITIVES SINCE 10/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALEXON-TREND CRYPTOSPORIDIUM MICROPLATE ASSAY MHJ ALEXON-TREND * 980402,980808,975006,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 *