BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2032774 · Received March 29, 2011

    Report

    Report Number
    1219913-2011-00040
    Date Received
    March 29, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA AND QC INDICATE THAT THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT FALSE POSITIVE ADVIA CENTAUR CP TROPONIN TEST RESULT. SAMPLE FIBRIN MAY BE A CONTRIBUTING CAUSE AND THE CUSTOMER WILL BE USING SAMPLE FILTERS. 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

    FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS AUTO REPEATED AND THE TROPONIN TEST RESULT WAS NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. 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 052

    Patients

    Seq Age Sex Outcome Treatment
    1