BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2853858 · Received December 3, 2012

    Report

    Report Number
    1061932-2012-02707
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED UNSTABLE LATRON VALUES AND THE RINSE BLOCK DRIPPED DILUENT FROM PRIMARY TO SECONDARY MODE. THE FSE DISCOVERED THE PROBE BENT AND STRAIGHTENED IT. THE CUSTOMER INFORMED THE FSE THAT THE INSTRUMENT AND ITS OPEN VIAL MODES WERE NOT MATCHING. THE FSE OBSERVED THAT THE OPEN VIAL CALIBRATION FACTORS ON THE INSTRUMENT WERE INCORRECT AND PERFORMED MODE-TO-MODE CALIBRATION AND RESOLVED THE ISSUE. THE FSE ALSO OBSERVED THE RINSE BLOCK LEAKED DILUENT DURING RINSE AND NOTED THE PROBE WAS BENT. THE FSE REPLACED THE BLOOD SAMPLING VALVE (BSV) AND PERFORMED MODE-TO-MODE CALIBRATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVERAL DROPS OF CLEAR FLUID LEAKED OUTSIDE THE INSTRUMENT FROM THE RINSE BLOCK, AND THE MANUAL PROBE WAS BENT INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ISSUES WITH DIFFERENTIAL SCATTER AND LATRON RECOVERY AFTER PERFORMING BLEACHING AND NOTICED RESIDUE AT THE MANUAL PROBE AFTER COMPLETING PATIENT SAMPLES. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS A RISK MANAGEMENT PLAN AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1