BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1163230 · Received September 15, 2008

    Report

    Report Number
    1219913-2008-00066
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE TROPONIN ULTRA RESULT WAS OBTAINED ON A PT SAMPLE, BUT WAS NOT REPORTED TO THE PHYSICIAN. BECAUSE THE ORIGINAL SAMPLE TUBE DID NOT HAVE ENOUGH SAMPLE FOR A RETEST, A SECOND SAMPLE FROM THE SAME PT WAS TESTED AND THE TROPONIN ULTRA RESULT WAS NEGATIVE. A THIRD SAMPLE WAS DRAWN AT A LATER TIME AND THE TROPONIN ULTRA RESULTS WERE ALSO NEGATIVE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HLTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 27

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR