BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1530858 · Received November 13, 2009

    Report

    Report Number
    2432235-2009-00201
    Event Type
    Other
    Date Received
    November 13, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 16, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS WAS DUE TO AN EMPTY WASH 1 RESERVOIR BOTTLE. THE FSE FILLED THE WASH 1 RESERVOIR AND PRIMED THE LINES. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULTS WERE OBTAINED ON MULTIPLE PT SAMPLES. THE CUSTOMER PROVIDED DATA ON ONE PT AND DECLINED TO SHARE THE OTHER PTS INFO EXCEPT TO SAY THAT THE PTS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND THE CORRECTED RESULTS WERE REPORTED. ONE PT UNDERWENT UNNECESSARY CARDIAC CATHETERIZATION. THERE WAS NO KNOWN ADVERSE HEALTH CONSEQUENCES TO THE PTS DUE TO THE TROPONIN ULTRA DISCORDANT RESULTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNOASSAY SYSTEM MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVIA CENTAUR XP NA

    Patients

    Seq Age Sex Outcome Treatment
    1