BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP AFP ASSAY

    MDR report key: 1414787 · Received July 8, 2009

    Report

    Report Number
    1219913-2009-00077
    Event Type
    Other
    Date Received
    July 8, 2009
    Date of Event
    June 22, 2009
    Report Date
    June 29, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOK
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT AFP RESULT WAS DUE TO A CUSTOMER TRANSCRIPTION ERROR. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE, DUE TO OTHER CUSTOMER CONCERNS WITH AUTO DILUTION RESULTS. THE FSE PERFORMED A SYSTEM MAINTENANCE, REPLACED ALL FOUR ASPIRATE WASH GUIDES AND ADJUSTED THE ASPIRATION PROBE DEPTH POSITION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW ADVIA CENTAUR XP AFP RESULT WAS REPORTED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PHYSICIAN QUESTIONED THE LOW RESULT AND THE PATIENT WAS REDRAWN AND THE AFP TEST REPEATED. THE REDRAWN PATIENT TEST RESULT WAS HIGH. REPEAT TESTING WAS PERFORMED ON THE ORIGINAL PATIENT SAMPLE AND THE RESULT WAS HIGH. THE CUSTOMER STATES THAT THE REPORTED LOW RESULT WAS DUE TO A TRANSCRIPTION ERROR. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, DUE TO THE REPORTED LOW DISCORDANT AFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY LOK SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 128

    Patients

    Seq Age Sex Outcome Treatment
    1