BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP ANTI-HBS ASSAY

    MDR report key: 2945153 · Received February 6, 2013

    Report

    Report Number
    1219913-2013-00022
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY REACTIVE ADVIA CENTAUR XP AHBS RESULT WHEN COMPARED TO REPEAT NON REACTIVE TEST RESULTS IS UNKNOWN. THE QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE TIME OF THE EVENT. THE PHYSICIAN HAD QUESTION THE RESULT DUE TO A REACTIVE HBSAG RESULT FOR THIS PATIENT. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS STATES THE FOLLOWING: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSE REACTIVE ADVIA CENTAUR CP AHBS RESULT WAS REPORTED BY THE CUSTOMER AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING WAS PERFORMED ON THE ORIGINAL PATIENT SAMPLE THE FOLLOWING DAY AND THE RESULTS WERE NON REACTIVE. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIALLY DISCORDANT AHBS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50682 ADVIA CENTAUR CP ANTI-HBS ASSAY AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 217

    Patients

    Seq Age Sex Outcome Treatment
    1