BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 1962114 · Received January 17, 2011

    Report

    Report Number
    2432235-2011-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 25, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 2432235-2011-00006 ON (B)(4) 2011. UPDATED (B)(4) 2012: IT WAS FOUND THAT A LOT OF BOVINE SERUM ALBUMIN (BSA) WAS THE CAUSE OF THE FALSE POSITIVE IMMULITE SYSTEMS TOXOPLASMA QUANTITATIVE IGG RESULTS, HOWEVER SIEMENS HAS INVESTIGATED THE ISSUE AND HAS DETERMINED THAT THE FREQUENCY OF THE FALSE POSITIVE PATIENT RESULTS REPORTED ARE WITHIN THE IFU SPECIFICITY CLAIMS OF (B)(4) FOR THE IMMULITE SYSTEMS TOXOPLASMA QUANTITATIVE IGG ASSAY.

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN REPORTS OF SYSTEM PROBLEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DISCORDANT HIGH TOXOPLASMA IGG (TXP) RESULTS WERE OBTAINED ON AN IMMULITE 2000 FOR (3) PATIENT SAMPLES FROM ONE PATIENT USING TXP LOT 360. THE TOXOPLASMA IGG RESULTS FOR THE 3 SAMPLES WERE INITIALLY NEGATIVE WHEN PREVIOUSLY TESTED WITH ANOTHER LOT OF IMMULITE TXP REAGENT. THE LABORATORY HAD THE SAMPLES RE-TESTED FOR TOXO IGA, IGG, AND IGM ANTIBODIES AT AN EXTERNAL LABORATORY - ALL RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA IGG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. IMMULITE 2000 360

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR