BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2147290 · Received May 26, 2011

    Report

    Report Number
    1061932-2011-00426
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 3 ML PLASTIC EDTA VACUTAINER TUBE AND WAS TESTED 5 MINUTES AFTER PHLEBOTOMY. CONTROLS WERE RUN BEFORE AND AFTER EACH SHIFT AND RECOVERED WITHIN RANGE. FLAGGING PREFERENCES ARE SET TO [1101] LOW LEVEL FOR BLAST, VARIANT LYMPH, AND IMM NE2; IMM NE 1 IS TURNED OFF, THEREFORE IMM. NE 1 IS NOT DISPLAYED ON THE PRINTOUT. (NOTE: BLAST, VARIANT LYMPH, IMM NE 2 AND IMM NE 1 ARE INSTRUMENT GENERATED FLAGS FOR IMMATURE WHITE BLOOD CELLS.). ON (B)(4) 2008, FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AT THE CUSTOMER'S FACILITY. THE FSE REVIEWED FIELD TREND DATA AND COLLECTED RAW DATA FROM THE INSTRUMENT. THE FSE VERIFIED THAT THE INSTRUMENT MET PERFORMANCE SPECIFICATIONS. RAW DATA ANALYSIS WAS PERFORMED. THE ROOT CAUSE FOR THE ERRONEOUS TEST RESULTS IS UNKNOWN; HOWEVER, THE INSTRUMENT GENERATED IMM NE1 FLAG ON THE INITIAL SAMPLE RUN AND WHICH WAS NOT VISIBLE ON THE PRINTOUT BECAUSE THE CUSTOMER DISABLED THE IMM NE 1 SENSITIVITY. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, CUSTOMER REPORTED AN ERRONEOUS EOSINOPHIL TEST RESULT OF 27.4% WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO THE MANUAL BLOOD SMEAR DIFFERENTIAL OF 0% EOSINOPHILS AND REPEAT TESTS PERFORMED ON THE SAME COULTER LH 750 HEMATOLOGY ANALYZER PROVIDED A TEST RESULT OF 0.0%. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE DOCTOR WAS NOTIFIED. THE TEST RESULTS WERE CORRECTED AT THE LIS (LABORATORY INFORMATION SYSTEM). THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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 UNK