BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1240880 · Received November 10, 2008

    Report

    Report Number
    2432235-2008-00136
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 18, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT RESULTS WAS DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE BASE IN THE ACID POSITION ON THE ADVIA CENTAUR INSTRUMENT. THE SIEMENS HEALTHCARE FSE DECONTAMINATED THE SYSTEM AND VERIFIED ASSAY PERFORMANCE WITH THE QC. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT ADVIA CENTAUR CKMB, VANCOMYCIN, CORTISOL, VALPROIC ACID, FERRITIN AND PROLACTIN RESULTS, DUE TO AN OPERATOR ERROR. THE OPERATOR PLACED THE BASE IN THE ACID POSITION ON THE INSTRUMENT. CUSTOMER HAD TO ISSUE CORRECTED REPORTS. CUSTOMER WILL NOT SHARE INFO REGARDING PT INTERVENTION, DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC. ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1