BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANTI-TG AB

    MDR report key: 4252251 · Received November 14, 2014

    Report

    Report Number
    2432235-2014-00650
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JZO
    PMA / PMN Number
    K991094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DISCORDANT, FALSELY ELEVATED ANTI THYROGLOBULIN ANTIBODY RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00650 WAS FILED ON NOVEMBER 14, 2014. THE FIRST SUPPLEMENTAL MDR WAS FILED ON DECEMBER 12, 2014.ADDITIONAL INFORMATION (01/14/2014): A SIEMENS REGIONAL SUPPORT CENTER (RSC) SPECIALIST REQUESTED THE PATIENT SAMPLE FOR ADDITIONAL TESTING, BUT IT IS NOT AVAILABLE. THE SAMPLES WERE NOT VIABLE FOR USE AS THE CUSTOMER STORED THE SAMPLE AT (-)80 DEGREES CELSIUS, WHICH IS NOT RECOMMENDED AS PER ANTI THYROGLOBULIN ANTIBODY (ATG) INSTRUCTIONS FOR USE. THE CAUSE OF FALSELY ELEVATED ATG RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, FALSELY ELEVATED RESULTS ON ONE PATIENT SAMPLE FOR ANTI THYROGLOBULIN ANTIBODY (ATG) ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT USING KIT LOT 598. THE SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM IN A REFERENCE LAB AND THE RESULT WAS LOWER. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON SAME INSTRUMENT AND THE RESULT WAS STILL ELEVATED. THE PATIENT SAMPLE WAS THEN TESTED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT IN A REFERENCE LAB AND THE RESULTS WERE STILL HIGH. IT IS UNKNOWN IF THIS WAS A NEW DRAW FROM THE PATIENT OR AN OLDER SAMPLE. THE SAMPLES WERE ALSO TESTED ON THREE ALTERNATE PLATFORMS IN A REFERENCE LAB AND THE RESULTS WERE LOWER. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE LOWER RESULTS FROM THE ALTERNATE PLATFORM WERE ALSO REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ATG RESULTS ON THE PATIENT SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, FALSELY ELEVATED RESULTS ON ONE PATIENT SAMPLE FOR ANTI THYROGLOBULIN ANTIBODY (ATG) ASSAY ON AN IMMULITE 2000 INSTRUMENT. THE REAGENT LOT WAS NOT PROVIDED BY THE CUSTOMER. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON SAME INSTRUMENT AND THE RESULT WAS STILL ELEVATED. THE SAMPLE WAS ALSO TESTED ON AN ALTERNATE PLATFORM IN A REFERENCE LAB AND THE RESULT WAS LOWER. ANOTHER NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON AN IMMULITE 2000 XPI INSTRUMENT AND THE RESULT WAS ELEVATED AGAIN. THE PATIENT SAMPLE WAS THEN TESTED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT IN A REFERENCE LAB AND THE RESULTS WERE STILL HIGH. IT IS UNKNOWN FROM THE COMPLAINT IF THIS WAS A NEW DRAW FROM THE PATIENT OR AN OLDER SAMPLE. THE SAMPLES WERE ALSO TESTED ON THREE ALTERNATE PLATFORMS IN A REFERENCE LAB AND THE RESULTS WERE LOWER. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE LOWER RESULTS FROM THE ALTERNATE PLATFORM WAS ALSO REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ATG RESULTS ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738596 IMMULITE 2000 ANTI-TG AB IMMULITE 2000 ANTI-TG AB JZO SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 ANTI-TG AB 598

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR