BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG

    MDR report key: 4190564 · Received October 21, 2014

    Report

    Report Number
    2432235-2014-00610
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LGD
    PMA / PMN Number
    K962936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # 2432235-2014-00610 WAS FILED ON OCTOBER 21, 2014.ADDITIONAL INFORMATION (12/12/2014): THE REGIONAL SUPPORT CENTER SPECIALIST SPOKE TO THE CUSTOMER. THE CUSTOMER DOES NOT HAVE SAMPLES FROM THE PATIENT AVAILABLE FOR TESTING. THE CAUSE OF THE DISCORDANT TOXOPLASMA QUANTITATIVE IGG RESULTS ON SAMPLES FROM ONE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE POSITIVE TOXOPLASMA QUANTITATIVE IGG RESULTS ARE UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE POSITIVE RESULTS ON ONE PATIENT SAMPLE FOR TOXOPLASMA QUANTITATIVE IGG (TXP) ON AN IMMULITE 2000 XPI INSTRUMENT WHEN USING REAGENT LOT 406. THE SAME SAMPLE WAS REPEATED WHICH ALSO RESULTED POSITIVE. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND TESTED ON THE IMMULITE INSTRUMENT, WHICH AGAIN RESULTED AS POSITIVE. THE FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE NEW SAMPLE WAS THEN TESTED ON ADVIA CENTAUR XP WHICH RESULTED AS NEGATIVE. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE RESULTS OF TOXO IGG ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667850 IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG LGD SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 406

    Patients

    Seq Age Sex Outcome Treatment
    1