BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY INSTRUMENT

    MDR report key: 3021892 · Received March 26, 2013

    Report

    Report Number
    1061932-2013-00470
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CONTROL INFORMATION PROVIDED SHOWED INTERMITTENT LOW, OUT OF RANGE RESULTS FOR THE WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND PLATELET (PLT) PARAMETERS DURING THE SPECIFIED TIME PERIOD IN QUESTION. THE CUSTOMER DID NOT SUPPLY ANY INFORMATION ON THE SAMPLE COLLECTION TYPE OR METHOD OF ANALYSIS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT OVER THREE DIFFERENT DAYS ((B)(4) 2013). ON (B)(4) 2013, THE FSE OBSERVED THAT DILUENT WAS FOUND IN THE ASPIRATION LINE PRIOR TO ASPIRATION. THE FSE DISCOVERED THAT THE LEE SOLENOID VALVE 68 (BACKWASH NEEDLE/SEGMENTS) REMAINED OPEN TOO LONG AND ORDERED A NEW VALVE AND THE DILUTER 3 BOARD FOR A RETURN VISIT. ON (B)(4) 2013, THE FSE RETURNED TO REPLACE THE VALVE 68 AND O-RINGS FOR MANIFOLD 4. THE FSE ALSO REMOVED, CLEANED, AND RE-ASSEMBLED THE BLOOD SAMPLING VALVE (BSV) AND THE SHEAR VALVES. THE FSE THEN REPLACED A FAULTY CHECK VALVE IN THE WHOLE PUMP ASPIRATION TUBING ASSEMBLY AND REPLACED THE NEEDLE VENT LINE TO THE VACUUM TRAP. THE FSE STILL OBSERVED SOME DILUENT WAS REMAINING IN THE ASPIRATION LINE AND WAS ADDED TO THE TUBE PRIOR TO ASPIRATION WHEN THE SYSTEM WAS TESTED. THE FSE RETURNED AGAIN ON (B)(4) 2013 AND REPLACED THE ASPIRATION LINE FROM THE NEEDLE TO THE BSV. THE FSE THEN REPLACED THE PINCH VALVE TUBING AT VALVE 59 AND 64. THE FSE ALSO REPLACED THE CHECK VALVE 25B (DILUENT ENTRY FROM BACKWASH TANK, AT TOP OF MANIFOLD 4). THE FSE ALSO REPLACED THE FAULTY FLUID DETECTOR ON THE VENT LINE AND ENABLED THE FLUID DETECTOR. THE SYSTEM WAS TESTED AGAIN WITH THE ADDITIONAL REPAIRS AND NO DILUTION WAS OBSERVED. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE WITH STARTUP, REPRODUCIBILITY, LATRON, AND 5C (ALL THREE LEVELS), WITH ALL RESULTS PASSING. THE FSE ALSO RAN TWO EMPTY SAMPLE TUBES, WITH NO DILUENT OBSERVED. THE CURRENT FAILURE MODE IDENTIFIED IS ATTRIBUTED TO THE MULTIPLE PARTS THAT WERE REPLACED DURING THE INSTRUMENT SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT SUSPECTING THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS DILUTING CONTROLS AND PATIENT SAMPLES. THE CUSTOMER REPORTED THAT TEN (10) SAMPLES GENERATED HEMOGLOBIN (HGB) RESULTS OF 12 G/DL AND UPON REPEAT DROPPED TO 8G/DL. THE CUSTOMER ALSO INDICATED THAT REPRODUCIBILITY WAS FAILING. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT THE SPECIFIC DATE OF INCIDENT OR PROVIDED PATIENT DATA. THE CUSTOMER REPORTED THAT THE DILUTION OF SAMPLES WAS FIRST SUSPECTED ON (B)(6) 2013. THE CUSTOMER ALSO REPORTED STABILITY ISSUES WITH 5C CONTROLS, AS DETECTED THROUGH INTERMITTENT DRIFTING. THE CONTROLS WERE LOW AND OUT OF RANGE, BUT CAME BACK IN RANGE WHEN A NEW VIAL WAS USED. THE CUSTOMER IS NOW AWARE THAT THIS IS BEING CAUSED BY A SLIGHT DILUTION OF THE CONTROL OVER TIME. THE CUSTOMER BELIEVES THAT THE SAMPLE DILUTION PROBLEM EXISTED ON THE LH 750 ANALYZER IN QUESTION SINCE (B)(6) 2013; HOWEVER, THE CUSTOMER INDICATED THAT THE PROBLEM WAS NOT OBVIOUS ON PATIENT SAMPLES UNTIL (B)(6) 2013. THE CUSTOMER INDICATED THAT ALL PATIENT SAMPLES FROM THE SUSPECTED PERIOD IN QUESTION HAVE BEEN REVIEWED AND IT WAS DETERMINED THAT THERE HAS BEEN NO AFFECT TO PATIENT TREATMENT DUE TO THE RESULTS OBTAINED. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT RESULTS FOR FURTHER REVIEW AND AS A RESULT INSTRUMENT FLAGGING FOR THE AFFECTED PATIENT RESULTS COULD NOT BE ASSESSED. THE USE OF THE LH 750 INSTRUMENT WAS DISCONTINUED WHEN THE PROBLEM WAS IDENTIFIED UNTIL SERVICE REPAIRS WERE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124454 COULTER® LH 750 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1