BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2912442 · Received January 12, 2013

    Report

    Report Number
    1061932-2012-02947
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT A PATIENT SAMPLE WITH KNOWN BLAST CELLS WAS RUN ON THE COULTER LH 750 HEMATOLOGY ANALYZER (LH 750). CUSTOMER REPORTED THE INSTRUMENT DID NOT GENERATE ANY FLAGS FOR THE PATIENT SAMPLE. THE RESULT WAS RELEASED OUT OF THE LABORATORY. THE FOLLOWING DAY THE PATIENT'S PHYSICIAN QUESTIONED THE RESULT. CUSTOMER REPORTED THEY THEN PERFORMED A MANUAL SMEAR. CUSTOMER REPORTED THEY RERAN THE SAMPLE ON THE LH 750 ANALYZER AND ALL THE APPROPRIATE FLAGS WERE GENERATED. THE SAMPLE WAS ALSO RERUN ON TWO OTHER INSTRUMENTS FOR VERIFICATION. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) COMPLETED A VIP (VERIFICATION INSPECTION PROCEDURE) AND COLLECTED RAW DATA FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19362 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR