BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1200387 · Received October 15, 2008

    Report

    Report Number
    1061932-2008-00054
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 20, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN STANDARD HEMOGARD VACUTAINER VACUUM TUBES AND WERE ANALYZED IN CLOSE VIAL MODE. QC IS RUN EACH SHIFT. QC WAS RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN RANGE. THE INSTRUMENT IS PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE 2008: INSPECTION OF THE INSTRUMENT LOCATED FLUID ACCUMULATING IN NEEDLE WASTE CHAMBER, INCOMPLETE DRAINING WAS NOTED. FSE REPLACED CHECK VALVE AT DRAIN LINE. FSE NOTED OCCLUSION AT BASE OF NEEDLE WASTE CHAMBER AND REMOVED AND CLEANED IT. FSE RAN MULTIPLE SAMPLES THROUGH PRIMARY MODE AND NEEDLE WASTE CHAMBER WAS DRAINING COMPLETELY. FSE PERFORMED SHUTDOWN, STARTUP, REPRODUCIBILITY AND CARRYOVER WITHOUT ERROR AND PERFORMED SYSTEM VALIDATION. FSE RETURNED ON-SITE THE NEXT DAY, WITH A HARDWARE SPECIALIST TO VERIFY VENT LINE SENSOR (VLS) SENSOR OPERATION. VLS SYSTEM WAS OPERATING CONSISTENTLY. INSTRUMENT WAS RELEASED FOR NORMAL OPERATION, FOLLOWING CONSULTATION WITH HARDWARE SPECIALIST. FSE REPLACED VLS SENSOR ONE WEEK LATER, PER CUSTOMER REQUEST. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS HEMOGLOBIN (HGB) AND PLATELETS (PLT) RESULTS GENERATED BY THE COULTER LH 750 ANALYZER FOR THREE PATIENTS. THE FIRST PATIENT SAMPLE WHEN TESTED GAVE AN HGB RESULT OF 7.1G/DL AND A PLT RESULT OF 142 X 10 TO THE THIRD POWER CELLS/UL AND WHEN RE-TESTED ON A DIFFERENT INSTRUMENT THE NEXT DAY, IT GAVE A HGB RESULT OF 7.7G/DL AND A PLT RESULT OF 160 X 10 TO THE THIRD POWER CELLS/UL. THE PATIENT WAS THEN RE-DRAWN AND THE SAMPLE WAS TESTED IN ANOTHER FACILITY UPON WHICH THE HGB RESULT WAS 12.2G/DL AND A PIT RESULT OF 268 X 10 TO THE THIRD POWER CELLS/UL. THE SECOND PATIENT SAMPLE GAVE A HGB RESULT OF 11.7G/DL AND A PLT RESULT OF 307 X 10 TO THE THIRD POWER CELLS/UL. THE PATIENT WAS RE-DRAWN AND RE-TESTED UPON WHICH THE HGB RESULT WAS 13.7G/DL AND PLT RESULT WAS 379 X 10 TO THE THIRD POWER CELLS/UL. THE THIRD PATIENT SAMPLE GAVE A HGB RESULT OF 12.3G/LD. UPON RE-TESTING ON DIFFERENT INSTRUMENTS, IT GAVE RESULTS OF 10.5, 10.3, 10.5G/DL AND IT WAS THEN RERUN ON THE ORIGINAL INSTRUMENT UPON WHICH IT GAVE A RESULT OF 10.4G/DL. THE PLT RESULTS FOR THIS SAMPLE WERE IN THE RANGE 56-70 X 10 TO THE THIRD POWER CELLS/UL. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT. ONE PATIENT WAS SENT TO ANOTHER FACILITY AND REDRAWN BUT NO TRANSFUSION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA