BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY

    MDR report key: 3143517 · Received June 3, 2013

    Report

    Report Number
    1219913-2013-00122
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 7, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS INITIALLY ASSESSED THIS EVENT AS NO POTENTIAL FOR INJURY; THEREFORE, NOT REPORTABLE. AFTER COMPLETION OF INTERNAL INVESTIGATIONS, A ROOT CAUSE FOR THE DISCORDANT RESULTS WAS DETERMINED, LEADING TO A NEW AWARENESS DATE FOR THIS EVENT OF (B)(6) 2013. INVESTIGATIONS CONCLUDED THAT A RARE VARIANT OF TSH, IDENTIFIED IN A SMALL CLUSTER OF PATIENTS, IS NOT DETECTED BY SIEMENS ADVIA CENTAUR SYSTEMS TSH3-ULTRA ASSAY. INVESTIGATION OF UNEXPLAINED DISCORDANT ADVIA CENTAUR TSH3-ULTRA RESULTS IDENTIFIED SAMPLES IN WHICH THE MONOCLONAL ANTIBODY USED IN THE REAGENT FAILED TO DETECT THE TSH MOLECULE. THESE INDIVIDUALS MAY HAVE A PREVIOUSLY UNRECOGNIZED, FUNCTIONALLY NORMAL TSH VARIANT. (B)(4). AS A RESULT, AN IMPORTANT PRODUCT SAFETY INFORMATION BULLETIN (B)(4) WAS SENT TO CUSTOMERS IN THE UNITED STATES AND AN URGENT FIELD SAFETY NOTICE (B)(4) WAS SENT TO CUSTOMERS OUTSIDE OF THE UNITED STATES IN MAY 2013, TO INFORM THEM OF THIS ISSUE. THESE CUSTOMER COMMUNICATIONS ALSO INCLUDED A REMINDER THAT, FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THESE ASSAYS SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS.

    Description of Event or Problem · 1

    FALSELY LOW ADVIA CENTAUR XP TSH3-ULTRA TEST RESULTS WERE OBTAINED BY THE CUSTOMER AND THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE TEST METHOD RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243534 ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY TSH3-ULTRA IMMUNOASSAY JLW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 263

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR