BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2461782 · Received February 20, 2012

    Report

    Report Number
    1061932-2012-00549
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A CLEAR LIQUID LEAK UNDERNEATH THE LASER ASSEMBLY OF THE COULTER LH 750 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THAT THE PATIENT RESULTS GENERATED BY THE LH 750 WERE DIFFERENTIAL 'R' FLAGGING. CUSTOMER REPORTED THAT DIFFERENTIAL "R" FLAGGING PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE FLOWCELL, SCATTER SENSOR, AND ALL SAMPLE LINES AFTER FINDING A SCRATCHED BOTTOM FITTING IN THE FLOW CELL THAT CAUSED THE LEAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1