BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN-COULTER

    MDR report key: 1190213 · Received October 6, 2008

    Report

    Report Number
    MW5008554
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BECKMAN-COULTER
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS A BECKMAN-COULTER "ACT5 DIFF AL" HEMATOLOGY ANALYZER, PUT IN USE 2005. THIS INSTRUMENT HAS REQUIRED OVER 36 SERVICE CALLS, WITH ABOUT 100 DAYS OF "DOWN-TIME", AND IS STILL EXHIBITING ERRONEOUS AND UNRELIABLE RESULTS. THIS FACILITY PROCESSES ABOUT 100 OUTPATIENT CBC TESTS PER DAY AND MUST REPEAT EACH ONE 3 TO 4 TIMES TO INSURE ACCURATE RESULTS. WE PERFORM AT LEAST 4 TIMES THE AMOUNT OF QUALITY CONTROL TESTING AND 10 TIMES THE AMOUNT OF LINEARITY/CALIBRATION VERIFICATION TESTING IN ORDER TO REPORT ACCURATE RESULTS. THE ADDITIONAL EXPENSES, DOWNTIME, PHYSICIAN AND PT INCONVENIENCE, HAS INCREASED AND THE MFR HAS NOT BEEN ABLE TO REMEDY THE SITUATION. THE SERVICE REPORTS WILL ATTEST TO THIS ONGOING PROBLEM, AS WILL THE DOCUMENTED ADDITIONAL EXPENSES AND CYCLES RUN VERSUS ACTUAL RESULTS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN-COULTER ACT5 DIFF AL HEMATOLOGY ANALYZER GKZ BECKMAN-COULTER ACT5 DIFF AL

    Patients

    Seq Age Sex Outcome Treatment
    1