BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPC IMMULITE

    MDR report key: 526367 · Received May 3, 2004

    Report

    Report Number
    MW1032001
    Event Type
    Malfunction
    Date Received
    May 3, 2004
    Report Date
    May 3, 2004
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RPTR IS USING THE DPC IMMULITE FOR RUNNING HBSAG TESTS. FALSE POSITIVE SCREENING RATE WENT FROM 3-4% TO 20%. AFTER MUCH TROUBLESHOOTING IT WAS DETERMINED THAT A WATER PUMP WAS NOT WORKING ADEQUATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPC IMMULITE IMMUNOCHEMISTRY ANALYZER JJE DIAGNOSTIC PRODUCTS CORP. DPC IMMULITE 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other