BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU640 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3112311 · Received May 14, 2013

    Report

    Report Number
    9612296-2013-00056
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND NOTICED THAT THE R2 (REAGENT 2) DISPENSE LOOKS LOW ON THE SAMPLE AND QC. THE FSE REPLACED THE R2 REAGENT VALVE, CLEANED AND MEASURED GROUND CONTACTS AT R2 WASH WELL AND PROBE COLLAR, AND ADJUSTED THE R2 MIXERS. FAILURE MODE IS ATTRIBUTED TO A FAILED R2 DISPENSER SOLENOID VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH URIC ACID RESULTS FOR MULTIPLE PATIENTS INVOLVING A BECKMAN COULTER AU640 CLINICAL CHEMISTRY ANALYZER. AN ERRONEOUSLY HIGH URIC ACID RESULT OF 6.5 MG/DL FOR ONE (1) PATIENT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER PROCEEDED TO RERUN QC (QUALITY CONTROL) AND NOTED THAT THE QC RESULTS WERE HIGH OUT OF THE ESTABLISHED RANGE. THE INSTRUMENT WAS RECALIBRATED AND QC RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER REPEATED THE INITIAL SAMPLE AND ISSUED AN AMENDED REPORT OF 4.3 MG/DL FOR URIC ACID. AFTER BECOMING AWARE OF THE ISSUE, THE CUSTOMER REPEATED FIVE (5) OTHER PATIENT SAMPLES AND RECOVERED LOWER URIC ACID RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY FOR THE OTHER FIVE (5) PATIENTS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212011 BECKMAN COULTER AU640 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU643-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1