BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3051655 · Received April 10, 2013

    Report

    Report Number
    1061932-2013-00611
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SCATTER MASK REPLACEMENT, VCS (VOLUME, CONDUCTIVITY, SCATTER) OPTIMIZATION AND CHEMICAL BALANCING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING HIGH EO (EOSINOPHILS) RESULTS FOR 2 PATIENT SAMPLES INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT MANUAL SMEARS OF THE SAMPLES REVEALED NO EO PRESENT AND WAS CONSIDERED CORRECT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. DATA REVIEW OF THE 2 SAMPLE RESULTS PROVIDED INDICATES THAT THE LH 750 GAVE LOWER NE% (NEUTROPHIL PERCENTAGE) AND HIGHER EO RESULTS WITHOUT INSTRUMENT-GENERATED FLAGS WHEN COMPARED TO RESULTS FROM MANUAL SMEARS. THE SAME SAMPLES WERE RERUN THE FOLLOWING DAY AND RESULTS CORRELATED TO THE MANUAL SMEARS AND WERE CONSIDERED CORRECT. QUALITY CONTROLS (QC) RUN BEFORE THE INCIDENT RECOVERED WITHIN LIMITS AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED THE ELEVATED EO RESULT. THE FSE REPLACED THE LASER, E-LYSE PUMP, SCATTER SENSOR, AND SCATTER MASK, SOL (SOLENOID) 60 AND 63, AND THE ACTUATORS FOR PINCH VALVE PV65 AND PV46B. THE FSE ALSO PERFORMED VCS (VOLUME, CONDUCTIVITY, SCATTER) OPTIMIZATION AND CHEMICAL BALANCING TO RESOLVE THE ERRONEOUSLY ELEVATED EO ISSUE. INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152186 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1