BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2180465 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-01025
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER MADE SEVERAL BARCODE READER ADJUSTMENTS AND REPLACED THE BARCODE RIBBON. HE ALSO PERFORMED A BARCODE READ RATE TEST WITH 100% ACCURACY. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE COMPLETION OF REPAIRS. THE ROOT CAUSE IS UNKNOWN BASED ON THE AVAILABLE INFORMATION. THE INSTRUMENT LOG AND ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRINTOUTS AND WORKSTATION DISPLAYS FOR FOUR PATIENT SAMPLES GENERATED FROM A COULTER LH 750 HEMATOLOGY ANALYZER POSSESSED PATIENT DEMOGRAPHICS BELONGING TO OTHER PATIENTS. THE RESULTS AND DEMOGRAPHICS IN THE LABORATORY INFORMATION SYSTEM (LIS), WHERE RESULTS ARE REPORTED FROM, WERE CORRECT FOR ALL PATIENTS. THE PRINTOUTS FOR ONLY ONE PATIENT INVOLVED IN THE EVENT WAS PROVIDED BY CUSTOMER AND CONFIRMED THE ISSUE. ALL SAMPLE BARCODES READ CORRECTLY AND THE PATIENT SAMPLES WERE RUN IN PRIMARY MODE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND HENCE NO DEATH, SERIOUS INJURY, OR AFFECT TO PATIENT TREATMENT WAS ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER INDICATED THAT THEY DO NOT REUSE PATIENT IDENTIFICATION NUMBERS AND THAT THE INSTRUMENT'S TO DO WORKLIST IS CLEARED EVERY DAY. THE INSTRUMENT'S CHECKSUM DIGIT WAS ENABLED DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1