BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1242556 · Received November 21, 2008

    Report

    Report Number
    1219913-2008-00100
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT WAS DUE TO OPERATOR ERROR. INVESTIGATIONS FOUND THAT THE OPERATOR RAN THE INCORRECT QC MATERIAL, WHICH FAILED SPECIFICATIONS. THE OPERATOR RE-CALIBRATED THE INSTRUMENT AND THE QC FAILED SPECIFICATION AGAIN. PATIENT SAMPLES WERE RUN EVEN THOUGH THE QC FAILED SPECIFICATION. A DIFFERENT OPERATOR RE-CALIBRATED THE INSTRUMENT AGAIN, THE CORRECT QC MATERIAL WAS RUN AND PASSED SPECIFICATION. THE PATIENT SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    NEGATIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVEN PATIENT SAMPLES AFTER THE QC MATERIAL FAILED SPECIFICATION. ONE PATIENT SAMPLE RESULT WAS REPORTED TO THE ER. UPON REPEAT, THE TROPONIN RESULTS WERE HIGHER THAN THE INITIAL VALUES. CORRECTED RESULTS WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO 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 TROPONIN ULTRA ASSAY TROPONIN IMMOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 28

    Patients

    Seq Age Sex Outcome Treatment
    1