BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)

    MDR report key: 3871296 · Received June 13, 2014

    Report

    Report Number
    1219913-2014-00143
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLW
    PMA / PMN Number
    K083844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS' FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CHECKED THE INSTRUMENT FOR LEAKS. THE FSE CHECKED THE WASH AND ASPIRATE PROBES- NO LEAKS FOUND. THE FSE CHECKED THE PROBE ALIGNMENTS AND NO PROBLEMS WERE FOUND. QUALITY CONTROL WAS RUN SUCCESSFULLY. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULT IS UNKNOWN. THERE HAVE BEEN NO ADDITIONAL INCIDENTS SINCE SERVICE WAS SENT IN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED FOR TSH ON THE ADVIA CENTAUR XP AND ON AN ALTERNATE TEST METHOD. THE RESULTS WERE HIGHER. REPEAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT AND ANOTHER ADVIA CENTAUR XP FOR TSH3-ULTRA AND THE RESULTS WERE AS EXPECTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350409 ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) TSH3-UL IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 270

    Patients

    Seq Age Sex Outcome Treatment
    1