BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CA 19-9 ASSAY

    MDR report key: 1221830 · Received November 4, 2008

    Report

    Report Number
    1219913-2008-00087
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS WAS DUE TO OPERATOR ERROR (THE ACID BULK BOTTLE WAS INSTALLED ON THE ADVIA CENTAUR SYSTEM IN THE WASH 1 SOLUTION BULK BOTTLE POSITION). THE ERROR WAS DETECTED BECAUSE THE QUALITY CONTROLS FOR TWO OTHER ASSAYS WERE ZERO'S WHEN THEY SHOULD HAVE READ VALUES. A SIEMENS FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER SITE AND DIRECTED THE TECHNICIAN TO REMOVE THE WASH 1 RESERVOIR, RINSE IT THOROUGHLY, DRY IT AND PLACE IT BACK ON THE SYSTEM. THE FSE ALSO INSTRUCTED THE TECHNICIAN TO CLEAN THE LINES, PRIME THE WASH 1 LINES MULTIPLE TIMES, AND PERFORM A DISPENSE WASH FLUID AND ASPIRATION. THE INSTRUMENT IS OPERATING AS INTENDED. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CORRECTED REPORT FOR AN ADVIA CENTAUR CA PT RESULT HAD TO BE ISSUED TO THE PHYSICIAN AS A RESULT OF OPERATOR ERROR. A TECHNICIAN NOTICED THAT THEIR QUALITY CONTROL RESULTS FOR THE ADVIA CENTAUR BNP AND TROPONIN ULTRA ASSAYS WERE ALL ZEROS. UPON FURTHER INVESTIGATION, THE TECHNICIAN REALIZED SHE HAD PLACED THE ACID BULK BOTTLE ON THE ADVIA CENTAUR IN THE WASH 1 SOLUTION BULK BOTTLE POSITION. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT CA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CA 19-9 ASSAY CA 19-9 IMMUNOASSAY NIG SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1