BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR HBC TOTAL(HBCT)

    MDR report key: 2012384 · Received March 9, 2011

    Report

    Report Number
    1219913-2011-00029
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 SAMPLE 4 TO BE TESTED ON AN ALTERNATE METHOD. THE RESULT WAS NEGATIVE FOR HBC TOTAL. THE RESULT MATCHED THE RESULT OBTAINED ON THE ADVIA CENTAUR. THERE WAS NO INDICATION IF THE PATIENT WAS VACCINATED. THE PATIENT HAS A VERY LOW AMOUNT OF THROMBOCYTES. BASED ON THE INFORMATION PROVIDED, THIS APPEARS TO BE A RECOVERED PATIENT. THE INSTRUCTIONS FOR USE, DISTRIBUTED IN THE US, STATES IN THE PERCENT AGREEMENT SECTION FOR RECOVERED HBV (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HBC TOTAL RESULT IS UNKNOWN. THE CALIBRATIONS AND DAILY QC WERE WITHIN RANGE FOR ALL THE RUNS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR HBC TOTAL RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE PATIENT HAD PREVIOUSLY TESTED (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBC TOTAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBC TOTAL(HBCT) HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 037

    Patients

    Seq Age Sex Outcome Treatment
    1