BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2500 HCG ASSAY

    MDR report key: 1851338 · Received September 23, 2010

    Report

    Report Number
    2017183-2010-00040
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 8, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHA
    PMA / PMN Number
    K990222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA AND INVESTIGATION HAS DETERMINED THAT THE FALSE NEGATIVE IMMULITE 2500 HCG TEST RESULT AND DISCORDANCY WHEN COMPARED TO ALTERNATE HCG TEST METHODS MAY BE ATTRIBUTED TO REAGENT SENSITIVITY BIAS AND IMPRECISION AT THE LOW END REAGENT ASSAY.

    Description of Event or Problem · 1

    A FALSE NEGATIVE IMMULITE 2500 HCG RESULT WAS OBTAINED ON A PT SAMPLE AND QUESTIONED BY THE PHYSICIAN. THE PT WAS REDRAWN TWO DAYS LATER AND THE REPEAT HCG RESULT WAS POSITIVE. THE DISCORDANT SAMPLE WAS TESTED AND COMPARED TO OTHER HCG TEST METHODS AND THE RESULTS WERE POSITIVE. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL FALSE NEGATIVE HCG ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 HCG ASSAY HCG IMMUNOASSAY DHA SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK