BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1212776 · Received October 24, 2008

    Report

    Report Number
    2432235-2008-00126
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE ACID IN THE WASH 1 POSITION ON THE ADVIA CENTAUR INSTRUMENT. A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE TO DECONTAMINATE THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT ADVIA CENTAUR HAVT, HBCT, AHAVM, AHCV, HBSAG, AHBS RESULTS, DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE ACID IN THE WASH 1 POSITION ON THE INSTRUMENT. CUSTOMER HAD TO ISSUE CORRECTED REPORTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER LOM SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1