BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR VB12 ASSAY

    MDR report key: 1663806 · Received April 19, 2010

    Report

    Report Number
    1219913-2010-00046
    Event Type
    Other
    Date Received
    April 19, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 8, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CDD
    PMA / PMN Number
    K993571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS REP REVIEWED THE ACCOUNT'S HISTORY AND NO ISSUES WERE FOUND IN THE TIME FRAME OF THE DISCORDANT RESULTS. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR VB12 RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR XP VB12 RESULT WAS OBTAINED ON A PT SAMPLE. TESTING OF A REDRAW SAMPLE FROM THE SAME PT PROVIDED A DIFFERENT RESULT. THE TECHNICIAN RETESTED THE INITIAL SAMPLE AND A LOWER RESULT WAS OBTAINED. THE PT SAMPLE WAS ALSO TESTED FOR FOLATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ADVIA CENTAUR VB12 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR VB12 ASSAY IMMUNOASSAY FOR VITAMIN B12 CDD SIEMENS HEALTHCARE DIAGNOSTICS INC NA 203

    Patients

    Seq Age Sex Outcome Treatment
    1