BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT TROPONIN I ASSAY

    MDR report key: 1163267 · Received September 15, 2008

    Report

    Report Number
    2017183-2008-00039
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 30, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    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 INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN AND CK-MB RESULTS IS UNK. IT IS SUSPECTED THAT CLOTS IN THE SAMPLE TUBES CAUSED THE DISCORDANT SAMPLE RESULTS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    POSITIVE IMMULITE 2500 TROPONIN AND CK-MB PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. UPON REPEAT, THE RESULTS WERE NEGATIVE. ANOTHER RETEST OF THE SAME SAMPLE CONFIRMED THE NEGATIVE RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN AND CK-MB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT TROPONIN I ASSAY TROPONIN IMMUNOASSAYS MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 132

    Patients

    Seq Age Sex Outcome Treatment
    1