BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2180972 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00658
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 3, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROLS WERE RUN BEFORE AND AFTER INCIDENT AND RECOVERED AS EXPECTED. FLAGGING PREFERENCES ARE SET TO '2202' (MID LEVEL FOR BLAST, VARIANT LYMPHOCYTE AND IMM NE 2. IMM NE 1 IS TURNED OFF) FOR BOTH INSTRUMENTS. NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES. THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT THE COUNT WAS LOW (5700), THE STABILISE PUMP VOLUME WAS LOW, AND THE TEMPERATURE MODE WAS HIGH. PUMP WAS REPLACED AND THE PNEUMATIC POWER SUPPLY WAS MOVED FROM RIGHT BELOW THE TRIPLE TRANSDUCER MODULE WHICH WAS CONTRIBUTING TO HIGH TEMPERATURE. REVIEW OF THE RAW DATA IDENTIFIED THAT THE SAMPLE SHOWED AND ABNORMAL PATTERN. THE LYMPHOCYTE POPULATION WAS MIXED WITH THE NEUTROPHIL AND MONOCYTE POPULATIONS. THE SAMPLE WAS FLAGGED WITH IMM NE 1 AT THE DEFAULT LEVEL AND THE VARIANT LYMPHOCYTE AT THE HIGHEST LEVEL. THE ALGORITHM IS DESIGNED TO SET BLAST FLAGS FOR SIMILAR SAMPLES, BUT IT WAS NOT SENSITIVE ENOUGH FOR THIS SAMPLE. THE ROOT CAUSE FOR THE LACK OF BLAST FLAGGING MAY BE RELATED TO THE STABILISE PUMP THAT WAS SUBSEQUENTLY REPLACED AND THAT THE ALGORITHM WAS NOT SENSITIVE ENOUGH TO FLAG THIS SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS W/O INSTRUMENT GENERATED FLAGS WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON MANUAL DIFFERENTIAL WITH 10% BLAST CELLS. THERE WERE INSTRUMENT GENERATED FLAGS FOR THE PRESENCE OF BLAST CELLS WHEN THE SAMPLE WAS TESTED USING A DIFFERENT COULTER LH 750 HEMATOLOGY ANALYZER IN THE LABORATORY. THE PT SAMPLE WAS EXPECTED TO HAVE LYMPHOBLASTS BASED ON THE PT HISTORY. THE ERRONEOUS DIFFERENTIAL RESULTS WERE REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT 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