BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3110281 · Received May 13, 2013

    Report

    Report Number
    9612296-2013-00060
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE SAMPLE PROBE, REAGENT SYRINGE, AND SAMPLE SYRINGE. THE FSE CONTINUED TO TROUBLESHOOT THE SYSTEM AND REPLACED THE S2 SAMPLE SOLENOID VALVE TO RESOLVE THE ISSUE. FAILURE MODE IS ATTRIBUTED TO A FAILED S2 SAMPLE SOLENOID VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING DISCREPANT CREATININE DILUTION RESULTS INVOLVING THE BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPORTED THAT A RESULT OF 8.85 MG/DL WAS OBTAINED FOR A PATIENT SAMPLE. THE CUSTOMER STATED THAT THE LABORATORY PERFORMS DILUTIONS ON ALL CREATININE RESULTS ABOVE 8.0 MG/DL AND THE SAMPLE WAS REPEATED AND RECOVERED A DILUTED REPEAT RESULT OF 4.03 MG/DL. THE DILUTED RESULT OF 4.03 MG/DL WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RERAN THE SAMPLE ON AN ALTERNATE ANALYZER AND RECOVERED A CREATININE RESULT OF 8.31 MG/DL WITH A DILUTED REPEAT RESULT OF 7.39 MG/DL. BECKMAN COULTER MADE SEVERAL ATTEMPTS TO REQUEST FOR DATA BUT WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210872 BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5431-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1