BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1198928 · Received October 8, 2008

    Report

    Report Number
    1061932-2008-00052
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    August 22, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 4ML BD EDTA VACUTAINERS AND STORED AT ROOM TEMP UNTIL DRAWN (0 TO 4 HRS) LATER. PREVIOUSLY-RUN PT SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. QC IS RUN 3 TIMES PER DAY. QC WAS RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ACCEPTABLE RANGES. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. TWO PIECES OF TUBING ATTACHED TO THE NEEDLE VENT CHAMBER - A VACUUM/PRESSURE SUPPLY AND THE NEEDLE VENT LINE WERE REVERSED AS TO WHICH PORT THEY WERE CONNECTED, CAUSING THE NEEDLE VENT LINE TO DRAW FLUID FROM THE BOTTOM OF THE NEEDLE VENT CHAMBER BACK INTO THE PT SAMPLE. FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008 AND CORRECTLY RETUBED THE NEEDLE VENT CHAMBER. THE IMPROPERLY REVERSED TUBING ON THE NEEDLE VENT CHAMBER MAY HAVE CONTRIBUTED TO THIS EVENT. 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 SEVERAL PTS. THE PT SAMPLE HGB RESULTS PROVIDED BY THE CUSTOMER WERE IN THE RANGE OF 6.1 - 7.5G/DL. UPON RE-TESTING ON A DIFFERENT INSTRUMENT, THE RESULTS WERE IN THE RANGE OF 5.2 - 7.6G/DL THE PLT RESULTS PROVIDED BY THE CUSTOMER WERE IN THE RANGE 112 - 272 X 10 TO THE THIRD POWER CELLS/UL AND WHEN TESTED ON A DIFFERENT INSTRUMENT, THE RESULTS WERE IN THE RANGE OF 113 - 259 X 10 TO THE THIRD POWER CELLS/UL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB AND QUESTIONED BY THE PHYSICIANS. RESULTS WERE BELIEVED TO BE ERRONEOUS BECAUSE HEMATOCRIT (HCT) RESULTS SIGNIFICANTLY CHANGED FROM PREVIOUS PT RESULTS. ONE PT WAS TRANSFUSED AND ONE PT WAS HELD BACK AN ADD'L 24 HRS IN ICU AND AT LEAST THREE PTS THAT WERE REFERRED TO THE HOSP TO DETERMINE IF TRANSFUSIONS WERE NEEDED BUT THEY WERE REDRAWN, RETESTED, AND WERE NOT TRANSFUSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA