BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2192302 · Received August 4, 2011

    Report

    Report Number
    1219913-2011-00107
    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
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION:THE CUSTOMER SENT THE PATIENT SAMPLES TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. THE RESULT WAS (B)(6) BY AN ALTERNATE METHOD AND THEREFORE INDICATES THE PRESENCE OF A MUTANT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HBSAG RESULTS IS UNKNOWN. A UNKNOWN INTERFERENCE SUBSTANCE MAY BE A CONTRIBUTING CAUSE. NO CONCLUSION CAN BE DRAWN. THE IFU STATES UNDER THE LIMITATION SECTION THE FOLLOW: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR HBSAG TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. IT IS RECOGNIZED THAT THE CURRENT METHODS FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN MAY NOT DETECT ALL POTENTIALLY INFECTED INDIVIDUALS. A (B)(6) TEST RESULT DOES NOT (B)(6)." 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 HBSAG RESULTS 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 HBSAG ASSAY RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR