BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 2192364 · Received August 4, 2011

    Report

    Report Number
    1219913-2011-00108
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT ADVIA CENTAUR XP HBCT TEST RESULT. THE PATIENT IS A RENAL DIALYSIS PATIENT AND AN INTERFERENCE SUBSTANCE MAY BE A CONTRIBUTING FACTOR. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE (B)(6) ADVIA CENTAUR XP HBCT RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE RESULT WAS QUESTIONED BY THE LABORATORY DIRECTOR AND WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR REPEAT TESTING BY ANOTHER TEST METHOD AND THE RESULT WAS (B)(6). THE (B)(6) RESULT AGREED WITH THE PATIENT'S CLINICAL HISTORY. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBCT ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) HBCT IMMUNOASAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR