BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2990830 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00336
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOGLOBIN AND HEMATOCRIT (H&H) CHECKS FAILED, MODE-TO-MODE NOT MATCHING, ELEVATED WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND LOW MEAN CELL VOLUME (MCV) RESULTS INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THE MANUAL CALIBRATION FACTORS WERE INCORRECTLY INPUTTED ON THE INSTRUMENT BY A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ON THE EVENT DATE. IT IS UNKNOWN IF THE QUESTIONED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FSE CLEANED THE BLOOD SAMPLING VALVE (BSV) AND SHEAR VALVES AND VERIFIED SYSTEM PERFORMANCE. THE FSE PERFORMED MODE-TO-MODE CALIBRATION, UTILIZING NORMAL CONTROL. THE FSE ADJUSTED WBC, RBC, HGB, AND MCV MANUAL CALIBRATION FACTORS AND RE-VERIFIED REPRODUCIBILITY IN THE MANUAL AND AUTO MODE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE ISSUE WAS RESOLVED, AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93043 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1