BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHENA MULTILYTE

    MDR report key: 663816 · Received January 10, 2006

    Report

    Report Number
    MW1037711
    Event Type
    Malfunction
    Date Received
    January 10, 2006
    Report Date
    January 10, 2006
    Manufacturer
    WAMPOLE
    Product Code
    DHN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS TO REPORT A PROBLEM WITH A LABORATORY ASSAY - NON LIFE THREATENING-THE PERFORMANCE CHARACTERISTICS OF THE ATHENA WAMPOLE/ZUES MULTILYTE KIT FOR ANA SCREENING DOES NOT AT ALL CORRELATE WITH PATIENT HISTORY, SIGNS AND SYMPTOMS. THE KIT IS DESIGNED TO DETECT LUPUS OR OTHER CONNECTIVE TISSUE DISEASE ASSOCIATED ANTIBODIES. AS A "SCREENING" METHOD IT HAS VERY POOR CORRELATION WITH PT PRESENTATION. THIS METHOD HAS A SENSITIVITY LEVEL WELL BEYOND WHAT IS CONSIDERED NORMAL, THEREBY DETECTING THE PRESENCE OF ANTIBODIES, ESPECIALLY RNP, AND TO A LESSOR EXTENT, SS-B, SCL-70 AND JO-1. RPTR'S LABORATORY HAS FOR THE LAST 3 MONTHS ROUTINELY RUN THESE SPECIMENS BY SECONDARY METHOD ONLY TO HAVE VERY FEW "CONFIRM" WITH WHAT WOULD BE A HIGH FALSE POSITIVITY RATE. FOR DIAGNOSED LUPUS PTS THIS TEST WORKS WELL, HOWEVER DOES NOT SEEM TO BE DESIGNED FOR SCREENING "ALL COMERS." RPTR HAS UNSUCCESSFULLY CONVINCED THE MFR THAT THERE IS A PROBLEM. THEY REFUSE TO CONFIRM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHENA MULTILYTE ANA TEST DHN WAMPOLE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *