BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR ANTI-HBSASSAY

    MDR report key: 1353767 · Received March 30, 2009

    Report

    Report Number
    1219913-2009-00036
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 20, 2009
    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

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA INDICATED THE SYSTEM CHECKS WERE FUNCTIONAL. THE FSE PROACTIVELY REPLACED THE HEATER COILS FOR PROBES 1 AND 3. THE CAUSE FOR THE DISCORDANT ANTI-HBS RESULTS CAN BE ATTRIBUTED TO OPERATOR ERROR DUE TO IMPROPER HANDLING AND PROCESSING OF SAMPLES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    POSITIVE ADVIA CENTAUR ANTI-HBS RESULTS WERE REPORTED TO THE PHYSICIAN FOR THREE DIFFERENT PT SAMPLES. PT #1, AND PT #2 REPEAT TESTING WAS POSITIVE. PT #3 REPEAT TESTING WAS NEGATIVE. THE CUSTOMER REPEATED PT #1 AND PT #2 SAMPLES A SECOND TIME WITH INCONSISTENT RESULTS. BOTH PT #1 AND PT #2 SAMPLES WERE RESPUN AND THE REPEAT TESTING RESULTS WERE NEGATIVE. THE FINAL ANTI-HBS RESULT REPORTED FOR ALL THREE PTS WERE NEGATIVE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ANTI-HBS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR ANTI-HBSASSAY AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 180

    Patients

    Seq Age Sex Outcome Treatment
    1