BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1777812 · Received July 30, 2010

    Report

    Report Number
    2050012-2010-00499
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND NOTICED THAT AN INADEQUATE DETERGENT WAS GOING TO MIX BAR ASSEMBLY WASH WELL, AND R1-OUTER WASH STATION WAS NOT GETTING ENOUGH WATER. THE FSE SERVICED THE INSTRUMENT AND REPLACED PARTS. AFTERWARDS, CALIBRATION AND QC PASSED, AND PRECISION WAS ACCEPTABLE. MALFUNCTION COULD HAVE AFFECTED OTHER TESTS CAUSING SERIOUS INJURY. HARDWARE ISSUE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE HIGH INORGANIC PHOSPHOROUS RESULTS GENERATED BY THE AU2700 CLINICAL CHEMISTRY ANALYZER FOR MULTIPLE PATIENTS. THE HIGH RESULTS WERE REPORTED OUT OF THE LAB AND A DOCTOR QUESTIONED ONE OF THE RESULTS. THE ORIGINAL PATIENT SAMPLES WERE RE-TESTED THE SAME DAY AND THE CORRECTED REPORTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER AU2700 CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU2700

    Patients

    Seq Age Sex Outcome Treatment
    1