BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1122363 · Received August 14, 2008

    Report

    Report Number
    2432235-2008-00090
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 2, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DISCORDANT RESULTS WAS DUE TO IMPROPER PRIMING OF THE WASH 1 FLUID BY THE CUSTOMER. THIS CAUSED THE WASH 1 RESERVOIR TO GO DRY CAUSING INSUFFICIENT WASHING OF THE SAMPLE CUVETTES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SEVERAL ELEVATED ADVIA CENTAUR BNP AND TROPONIN ULTRA RESULTS WERE OBTAINED ON PATIENT SAMPLES. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. QC SAMPLES WERE REPEATED AND OUT OF RANGE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN AND BNP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNO-ASSAY ANALYZER MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1