BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 1874239 · Received October 13, 2010

    Report

    Report Number
    1219913-2010-00122
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. THE CUSTOMER DECLINED SERVICE - NO FURTHER ACTION TAKEN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED FOR A PT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULT. THE PT SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. PT TREATMENT WAS NOT PRESCRIBED OF ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 045

    Patients

    Seq Age Sex Outcome Treatment
    1