BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2983047 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00294
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE WAS DETERMINED TO BE THE LIGHT SCATTER (LS) SENSOR, FLOW CELL ALIGNMENT, AND LS PREAMP GAIN AND SAMPLE PRESSURE NEEDING ADJUSTMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BASOPHILS (BA) RECOVERY ISSUE DURING A WEEKLY CORRELATION STUDY PERFORMED ON THEIR TWO LH 500 HEMATOLOGY ANALYZER USING PATIENT SAMPLES AS CONTROLS. THE CUSTOMER NOTED THAT ABOUT 6 OUT OF 10 SAMPLES WERE NOT WITHIN THE SPECIFICATION FOR THE BA PARAMETER ONLY. THE CUSTOMER INDICATED THAT ONE OF THE LH 500 ANALYZER GAVE HIGHER BASOPHIL RESULTS COMPARED TO THE ALTERNATE LH 500 ANALYZER. NO PREVIOUSLY RUN PATIENT SAMPLES WERE CONSIDERED ERRONEOUS NOR ERRONEOUSLY REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. PATIENT SAMPLE PRINTOUTS FROM THE CORRELATION STUDY WERE NOT PROVIDED AND ARE NO LONGER AVAILABLE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND EVIDENCE OF A PRIOR LEAK WHICH OCCURRED DURING THE LAST RECENT PREVENTATIVE MAINTENANCE (PM). NO ACTIVE LEAK WAS OBSERVED AND THERE WAS NO REPORT OF EXPOSURE OR INJURY AS A RESULT OF THE PRIOR LEAK. THE FSE REPLACED THE LIGHT SCATTER (LS) SENSOR, ALIGNED THE FLOW CELL, AND ADJUSTED THE LS PREAMP GAIN AND SAMPLE PRESSURE TO CORRECT LATRON COUNT TIMES. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86526 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1