BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG

    MDR report key: 1933453 · Received December 15, 2010

    Report

    Report Number
    1219913-2010-00159
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT FALSE REACTIVE ADVIA CENTAUR (B)(6) TEST RESULTS. THE REACTIVE SERUM (B)(6) TEST RESULTS WERE CONFIRMED REACTIVE WITH A CONFIRMATORY TEST RESULT. SAMPLE HANDLING IS SUSPECT AND MAY HAVE BEEN A CONTRIBUTING FACTOR. THERE IS INSUFFICIENT PT SAMPLE AVAILABLE FOR FURTHER INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE REACTIVE ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER AND CONFIRMED WITH CONFIRMATORY TESTING. THE PT WAS LATER REDRAWN FOR (B)(6) AND OTHER (B)(6) TEST MARKERS, AND THE RESULTS WERE NON REACTIVE. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR (B)(6) ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBSAG HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1