BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 2132638 · Received June 17, 2011

    Report

    Report Number
    2432235-2011-00092
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K902336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE REPLACED ASPIRATE WASH TUBING AND WASH STATIONS. THE FSE THEN RAN CONTROLS AND ALL WERE WITHIN RANGE. NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CAUSED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR CP TROPONIN RESULTS WERE OBTAINED ON ONE (1) PATIENT SAMPLE. THE LABORATORY TYPICALLY RUNS TROPONIN SAMPLES IN DUPLICATE. DUPLICATE SAMPLES IN THIS CASE WERE INCONSISTENT, SO THE SAMPLES WERE REPEATED WHICH ALSO GAVE INCONSISTENT RESULTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP DIAGNOSTICS AUTOMATED CHEMILUMINECSENSE SYSTEM (ACS) CENTAUR ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1