BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    MDR report key: 1783533 · Received July 29, 2010

    Report

    Report Number
    1219913-2010-00086
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHX
    PMA / PMN Number
    K911121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY SUSPECTS THAT THE DISCORDANT RESULTS ARE DUE TO INTERFERENCE WITH THE PT'S MEDICATIONS. A SIEMENS' REPRESENTATIVE REVIEWED THE CALIBRATIONS AND THE QC. NO ISSUES WERE IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. 510(K) # FOR TROPONIN: K053020. ADDITIONAL EXPIRATION DATE: 12/25/2010.

    Description of Event or Problem · 1

    NEGATIVE ADVIA CENTAUR CKMB AND TROPONIN ULTRA RESULTS WERE OBTAINED ON A PT SAMPLE AND REPORTED. A TECHNICIAN ON THE DAY SHIFT NOTICED THAT THIS PT HAD A HIGH TOTAL CK AND THE OTHER CARDIAC MARKERS WERE LOW. THE SAME PT SAMPLE WAS RETESTED AND THE RESULTS WERE POSITIVE. A CORRECTED REPORT WAS ISSUED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED DUE TO THE DISCORDANT CKMB AND TROPONIN ULTRA RESULTS. THE CUSTOMER REPORTED THAT THE PT PASSED AWAY ON (B)(6) 2010. THE CUSTOMER STRESSED THAT THE PT'S DEATH WAS NOT DUE TO ANY INCORRECTLY REPORTED RESULTS. THE CUSTOMER STATED THAT THE PT WAS ON MULTIPLE DRUGS AND WAS EXTREMELY ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY CKMB AND TROPONIN IMMUNOASSAY JHX SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 157/043

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR