BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 1911528 · Received November 24, 2010

    Report

    Report Number
    1219913-2010-00146
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED A FUNCTIONAL SYSTEM CHECK AND OBSERVED NO SYSTEM ISSUES. IT WAS NOTED THAT THERE WAS ONLY ENOUGH SAMPLE AVAILABLE AT THE TIME TO RUN THE INITIAL AND REPEAT TESTS. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENTS ARE PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED ON A PT SAMPLE AND REPEATED POSITIVE ON ANOTHER ADVIA CENTAUR CP INSTRUMENT. THE PT WAS REDRAWN AND RETESTED FOR TROPONIN AND THE RESULTS WERE NEGATIVE. THE PT WAS TRANSFERRED FROM THE EMERGENCY DEPARTMENT (ED) TO THE CARDIAC FLOOR INSTEAD OF MEDICAL SURGERY. 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. NA 047

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR