BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2242302 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01405
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT. QC RESULTS WERE ACCEPTABLE. RAW DATA WAS REQUESTED BUT HAS NOT BEEN RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. PER LABELING, PLATELET CLUMPS ARE LISTED AS KNOWN INTERFERING SUBSTANCES FOR THE WBC AND PLATELET PARAMETERS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY OBTAINED ERRONEOUS LOW PLATELET (PLT) RESULTS WITHOUT INSTRUMENT GENERATED MESSAGES FOR ONE (1) PATIENT. THE RESULTS WERE OBTAINED ON A COULTER LH 750 HEMATOLOGY ANALYZER. THIS PATIENT SAMPLE PREVIOUSLY HAD PLATELET CLUMPING ISSUES. REPEAT ANALYSIS OF THE PATIENT SAMPLE ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT YIELDED HIGHER PLT RESULTS WITH INSTRUMENT GENERATED MESSAGES. REVIEW OF DATA PROVIDED ALSO SHOWS DISCREPANT WHITE BLOOD CELL (WBC) COUNTS WITHOUT INSTRUMENT GENERATED MESSAGES FOR THE INITIAL RUN AND INSTRUMENT GENERATED CELLULAR INTERFERENCE MESSAGES FOR SAMPLE RERUNS. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, THUS DID NOT HAVE AN EFFECT ON PATIENT TREATMENT.

    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. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR