BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2151778 · Received July 6, 2011

    Report

    Report Number
    1061932-2011-00841
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RUN PRIOR TO THE EVENT RECOVERED WITHIN RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE APERTURE VOLTAGES AND FLOW RATE WERE SET CORRECTLY. THE FSE VERIFIED THE INSTRUMENT, REVIEWED THE LASER OFFSET VOLTAGES, AND VALIDATED THE SYSTEM. RAW DATA ANALYSIS INDICATES: PATIENT 1: THE PLT COUNT (~222) IS IN THE NORMAL RANGE AND THE OVERALL PATTERN ON THE SPECIMEN RUN IS QUITE NORMAL. FROM A PATTERN PERSPECTIVE. PLATELET CLUMPS ARE NOT OBSERVED FROM THE INSTRUMENT RESULTS. PATIENT 2: INTERFERENCE IS DETECTED ON THE FRONT OF THE WBC HISTOGRAM BUT NOT SUFFICIENT TO SUSPECT THAT THE PLATELET RESULTS ARE NOT CORRECT AND NOT SUFFICIENT TO GENERATE A SUSPECT MESSAGE. PER LABELING, THE FOLLOWING ARE LISTED AS KNOW INTERFERING SUBSTANCES FOR THE PLATELET PARAMETER: GIANT PLATELETS, PLATELET CLUMPS, WHITE CELL FRAGMENTS, ELECTRONIC NOISE, VERY SMALL RED CELLS, RED CELL FRAGMENTS. ROOT CAUSE PER RAW DATA ANALYSIS IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT PLATELET (PLT) COUNTS ON 2 SPECIMENS ANALYZED ON THE COULTER LH 750 HEMATOLOGY ANALYZER WERE NOT ACCURATE BECAUSE CLUMPED PLTS WERE OBSERVED ON A MANUAL REVIEW OF THE SMEARS AND STATED THE LH750 IS NOT GENERATING A PLT CLUMPS FLAG WHEN PLT CLUMPS ARE PRESENT ON SMEARS. THE CUSTOMER DID NOT REPORT THE PLT COUNTS OUTSIDE OF THE LABORATORY, BUT INDICATED THE PLTS WERE "CLUMPED BUT ADEQUATE". THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1