BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBC TOTAL (HBCT)

    MDR report key: 1622439 · Received February 19, 2010

    Report

    Report Number
    1219913-2010-00020
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 5, 2010
    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

    THE CAUSE FOR THE FALSE NEGATIVE (B)(6) TOTAL RESULT IS UNKNOWN. A SIEMENS REPRESENTATIVE EXAMINED THE (B)(6) TOTAL QC AND CALIBRATIONS. NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON FEBRUARY 19, 2010. (B)(6) 2012: ADDITIONAL INFORMATION: (B)(6) 2010: THE SAMPLE IS OF A PATIENT WITH A KNOWN PAST INFECTION AND NOT A POSITIVE POOL INTERNAL CONTROL SAMPLE AS WAS STATED IN THE INITIAL MDR. THE CUSTOMER USES THIS SAMPLE AS AN ADDITIONAL INTERNAL CONTROL. (B)(6) FOR THE SAMPLE. (B)(6) 2010: THE CUSTOMER SENT AN ALIQUOT OF THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. THE COLLECTIVE DATA GENERATED AT THE CUSTOMER SITE AND AT SIEMENS SUGGESTS THAT THE PATIENT SAMPLE USED AS A SECONDARY CONTROL BY THE CUSTOMER WILL MEASURE BOTH ABOVE AND BELOW THE ASSAY CUT OFF. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR (B)(6) TOTAL RESULT WAS OBTAINED ON A POSITIVE POOL INTERNAL CONTROL SAMPLE. THE CUSTOMER ALWAYS RUNS A POSITIVE POOL SAMPLE FOR (B)(6). THE POSITIVE POOL SAMPLE WAS TESTED WITH A DIFFERENT METHOD AND THE RESULT WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBC TOTAL (HBCT) HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 032

    Patients

    Seq Age Sex Outcome Treatment
    1