BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2991271 · Received March 6, 2013

    Report

    Report Number
    1061932-2013-00284
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT THE BSV KNOB WAS LOOSE. BEC CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER OVER THE PHONE AND HAD THE CUSTOMER TIGHTEN THE BSV KNOB, RUN SAMPLES, AND VERIFY THAT THE BSV NO LONGER LEAKED. THE CUSTOMER RERAN SAMPLES AND VERIFIED THAT ALL RESULTS MATCHED THE SAME SAMPLES RUN ON THEIR OTHER INSTRUMENT. THESE RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THE CAUSE OF THIS EVENT IS ATTRIBUTED TO A LOOSE BSV KNOB.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT HIGH RBC AND PLATELET (PLT) RESULTS GENERATED BY A COULTER LH 780 HEMATOLOGY ANALYZER ON 5 PATIENT SAMPLES. THE CUSTOMER ALSO REPORTED THAT THE BSV (BLOOD SAMPLING VALVE) LEAKED APPROXIMATELY 5ML OF DILUTED BLOOD ONTO THE TABLE TOP. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. ONLY ONE RESULT HAD AN INSTRUMENT GENERATED R FLAG FOR THE PLT PARAMETER. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO INJURY OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT. THE PATIENT SAMPLES WERE RUN ON THE CUSTOMER'S OTHER INSTRUMENT WHERE RESULTS WERE CONSIDERED CORRECT AND REPORTED OUT. CORRESPONDING CORRECT RESULTS WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96313 COULTER® LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR