BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183618 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00750
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    March 2, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN 4 HOURS BEFORE THIS INCIDENT AND WERE WITHIN ACCEPTABLE RANGES. THE INSTRUMENT SENSITIVITY WAS SET AT 2202, WHICH IS MID-LEVEL FOR ALL BLAST FLAGS EXCEPT FOR IMM. NE 1 WHICH HAD BEEN TURNED OFF. NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. SERVICE DID NOT EVALUATE ANALYZER. ON (B)(6) 2008, A RECOMMENDATION WAS MADE TO ADD DEFINITE FLAG TO LY% (LYMPHOCYTE%). RAW DATA ANALYSIS WAS CONDUCTED AND DETERMINED THAT THE ALGORITHM FAILED TO FLAG THIS POPULATION WITH EITHER BLAST OR VARIANT LYMPH FLAG. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00749.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS WERE OBTAINED WHILE USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR THESE TEST RESULTS. THE RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON A MANUAL DIFFERENTIAL WITH BLAST CELLS PRESENT. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUTSIDE THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR THE SECOND OF TWO ANALYZERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO