BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1842893 · Received September 23, 2010

    Report

    Report Number
    1061932-2010-00159
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT'S QC IS WITHIN SPECIFICATION WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN ONCE EVERY SHIFT AND WERE WITHIN ASSAY LIMITS PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) RAN REPRODUCIBILITY, CHECKED THE INSTRUMENT DILUENT DELIVERY AND VERIFIED THE INSTRUMENT'S OPERATION. ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY HIGH WBC RESULT WITHOUT INSTRUMENT FLAGS GENERATED BY COULTER LH 750 ANALYZER. THE PATIENT HAD TWO TUBES DRAWN AT THE SAME TIME AND BOTH TUBES WERE RUN ON THE SAME LH750 INSTRUMENT. THE FIRST TUBE GENERATED THE CORRECT WBC RESULTS ON THE INITIAL AND RERUN SAMPLING. THE SECOND TUBE GENERATED ERRONEOUS HIGH WBC RESULTS ON THE INITIAL SAMPLING AND CORRECT WBC RESULT ON RERUN. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT. NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1