BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2211832 · Received August 15, 2011

    Report

    Report Number
    1219913-2011-00112
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 26, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED A VISUAL CHECK OF FLUIDICS AND MEASURING UNIT AND FOUND NO ISSUES WITH LUMO OR WASH STATION. AS A PRECAUTION, THE FSE REPLACED BASE PUMP TUBING. THE CAUSE FOR THE DISCORDANT POSITIVE TROPONIN RESULT IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT REPLICATE TEST RESULT. THE CUSTOMER PERFORMS DUPLICATE TROPONIN TESTING ON ALL PATIENT SAMPLES. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 055

    Patients

    Seq Age Sex Outcome Treatment
    1