BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2853535 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01888
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: REAGENT PROBE MISALIGNMENT AND CRANE ASSEMBLY ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING ERRONEOUSLY HIGH CREATININE RESULTS FROM THE BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER PROVIDED ONE VERBAL RESULT THAT A PATIENT RECOVERED 16 MG/DL FOR BUN (BLOOD UREA NITROGEN) AND 3.45 MG/DL FOR CREATININE. THE CUSTOMER NOTED THAT THE PATIENT WAS REQUESTED TO RETURN TO THE HOSPITAL FOR A SAMPLE REDRAW 8 HOURS LATER AND A REPEAT RUN GAVE A RESULT OF 15 MG/DL FOR BUN AND 1.62 MG/DL FOR CREATININE. A CORRECTED REPORT WAS ISSUED AND THERE WAS NO CHANGE TO PATIENT TREATMENT OR REPORT OF INJURY ASSOCIATED WITH THE EVENT. THE CUSTOMER HAD VERIFIED THAT THE SAMPLE REDRAW WAS THE ONLY AFFECT TO THE PATIENT. THE CUSTOMER HAD PROVIDED INSTRUMENT PRINTOUTS FOR A PATIENT BUT IS DIFFERENT THAT THE ONE VERBALLY COMMUNICATED. THE INSTRUMENT PRINTOUTS PROVIDED BY THE CUSTOMER INDICATED THAT A CREATININE RESULT OF 2.46 MG/DL AND A BUN RESULT OF 8 MG/DL WERE OBTAINED. THE SAMPLE WAS THEN RERUN FOR CREATININE 4 MINUTES AFTER THE INITIAL RUN AND A RESULT OF 0.60 MG/DL WAS OBTAINED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DISCOVERED THE REAGENT PROBE MISALIGNED TO THE WASH STATION. THE FSE ALSO NOTED THAT THE CRANE ASSEMBLY WHICH DRIVES THE PROBE UP AND DOWN WAS STICKY TO THE TOUCH. THE FSE THEN CHECKED THE PROBE FOR BENDS OR BARBS, REALIGNED THE PROBE TO THE WASH STATION AND CLEANED AND LUBRICATED THE CRANE ASSEMBLY. THE INSTRUMENT WAS THEN VERIFIED PER ESTABLISHED PROCEDURES. UPON FOLLOW UP WITH THE CUSTOMER AFTER THE REPAIR, THE CUSTOMER ALSO DISCOVERED A MINOR CUVETTE OVERFLOW SITUATION WHICH DUE TO A CHIPPED CUVETTE ON (B)(4) 2012. THE CUSTOMER BELIEVED THE CHIPPED CUVETTE WAS CAUSED BY THE REAGENT PROBE MISALIGNMENT WHICH WAS ALREADY CORRECTED BY THE FSE. THE CUSTOMER FOLLOWED THE OVERFLOW PROTOCOL IN THE USER GUIDES AND HAVE HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMA K.K. AU5421-02

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR