BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 3811283 · Received May 15, 2014

    Report

    Report Number
    1219913-2014-00119
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, NON-REPRODUCIBLE, (B)(6) RESULT IS UNKNOWN. SUBSEQUENT TESTING RESULTS OF THE PRIMARY TUBE AND A NEW SAMPLE DRAWN FROM THE SAME PATIENT WERE (B)(6). THE ISSUE APPEARS TO BE SPECIFIC TO THE SAMPLE. A SIEMENS FIELD SERVICE ENGINEER PERFORMED A TOTAL SERVICE CALL AND VERIFIED REAGENT PROBE 3 CALIBRATIONS. THE SYSTEM IS PERFORMING WITHIN SPECIFICATION. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR (B)(6) TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A (B)(6) RESULT WHEN COMPARED TO REPEAT TESTING OF THE PRIMARY SAMPLE AND A NEW DRAW FROM THE SAME PATIENT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE DISCORDANT RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THE DISCORDANT ADVIA CENTAUR (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290705 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 063178

    Patients

    Seq Age Sex Outcome Treatment
    1