BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CEA AND BR ASSAY

    MDR report key: 1067342 · Received June 27, 2008

    Report

    Report Number
    1219913-2008-00050
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    April 30, 2008
    Report Date
    June 3, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHX
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE CLEANED ALL PROBES AND PERFORMED DISPENSE TESTS TO VERIFY SYS OPERATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE FSE ALSO DETERMINED THAT THE CUSTOMER WAS USING THE INCORRECT RANGES FOR THEIR BR QC AND THE ASSAY CALIBRATORS WERE NOT RECONSTITUTED PROPERLY. NO FURTHER EVALUATION FOR THE DEVICE IS REQUIRED. ADD'L 510K # FOR BR IS K982680. ADDITIONAL CATALOG# IS: 02419937.

    Description of Event or Problem · 1

    ELEVATED ADVIA CENTAUR CEA AND BR (CA 27.29) RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THEM AND HAD THEM RETESTED. UPON RETEST, CORRECTED REPORTS FOR THE CEA AND BR RESULTS WERE GENERATED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCREPANT CEA AND BR ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CEA AND BR ASSAY CEA AND BR ASSAYS DHX SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1