BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2192363 · Received August 4, 2011

    Report

    Report Number
    1219913-2011-00106
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4), 2011.(B)(4) 2012: ADDITIONAL INFORMATION:THE CUSTOMER SENT THE PATIENT SAMPLES TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. IN-HOUSE TESTING BY THE ADVIA CENTAUR AND AN ALTERNATE METHOD CONFIRMED THE CUSTOMER'S OBSERVATION OF THE NEGATIVE RESULT.ISOLATED MUTATED SAMPLES THAT ARE NOT DETECTED BY THE ADVIA CENTAUR HBSAG ASSAY MAY BE A POSSIBLE CAUSE.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE ) PERFORMED A PERIODIC MAINTENANCE CHECK AND THE CAUSE FOR THE DISCORDANT HBSAG RESULTS IS UNKNOWN. 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

    TWO FALSE (B)(6) ADVIA CENTAUR XP HBSAG RESULTS WERE OBTAINED BY THE CUSTOMER AND DISCORDANT WHEN PERFORMING A HBSAG ASSAY METHOD COMPARISON AND COMPARED TO OTHER HBSAG TEST METHODS. THERE WAS NO KNOWN 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