BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANTI -TPO AB

    MDR report key: 4277550 · Received November 25, 2014

    Report

    Report Number
    2432235-2014-00694
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944)
    Product Code
    JZO
    PMA / PMN Number
    K991096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE CUSTOMER'S ANTI-TPO AB DATA. THE HSC OBSERVED THAT THE VALUES OF THE IMPRECISE RESULTS WERE NEAR THE ASSAY SENSITIVITY LEVEL. THE CAUSE OF IMPRECISE ANTI-TPO RESULTS IS RELATED TO TRUE VALUE OF THE PATIENT SAMPLE BEING NEAR THE SENSITIVITY LEVEL.

    Description of Event or Problem · 1

    IMPRECISE ANTITHYROID PEROXIDASE ANTIBODY (ANTI-TPO AB) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE WHEN RUN IN DUPLICATE ON AN IMMULITE 2000 XPI INSTRUMENT USING KIT LOT 611. THE SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT IN REPLICATES OF TWO AND THREE AND RESULTS WERE STILL IMPRECISE. IT IS UNKNOWN IF ANY OF THE IMPRECISE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS SENT TO REFERENCE LAB AND WAS TESTED WITH AN ALTERNATE METHODOLOGY AND A CORRECTED RESULT WAS OBTAINED. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION OBTAINED ON ANTI-TPO AB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765696 IMMULITE 2000 ANTI -TPO AB IMMULITE 2000 ANTI -TPO AB JZO SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) IMMULITE 2000 611

    Patients

    Seq Age Sex Outcome Treatment
    1