BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AC T DIFF 2 ANALYZER

    MDR report key: 947722 · Received November 12, 2007

    Report

    Report Number
    1061932-2007-00054
    Event Type
    Other
    Date Received
    November 12, 2007
    Date of Event
    October 18, 2007
    Report Date
    November 12, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE A DAY. QC WAS PERFORMED BEFORE AND AFTER THE EVENT AND RESULTS WERE IN RANGE. THE SPECIMEN WAS COLLECTED IN A BD, 4ML TUBE AND RAN LESS THAN 15 MINUTES AFTER COLLECTION. THE SAMPLE WAS TESTED IN CLOSED VIAL WHOLE BLOOD MODE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: A) PER FSE, QC WAS PERFORMING PROPERLY. B) THE FSE INSPECTED FLUIDICS AND VERIFIED MIXING BUBBLES. C) THE FSE PERFORMED REPRODUCIBILITY USING NORMAL CONTROL MATERIAL AND OBTAINED PASSING RESULTS. D) THE FSE VERIFIED THE INSTRUMENT'S PERFORMANCE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN 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 LOW HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS THAT WERE GENERATED BY THE COULTER AC T DIFF 2 INSTRUMENT FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR HGB AND PLT AND RESULTS OF 4.2G/DL AND 240 X 10 TO THE THIRD POWER CELLS/UL WERE OBTAINED RESPECTIVELY. THE RESULTS WERE REPORTED OUT OF THE LAB AND THE PATIENT WAS SENT TO A HOSPITAL AND REDRAWN. THE HOSPITAL'S RESULTS WERE HIGHER FOR BOTH ANALYTES; HGB RESULT WAS 9.1G/DL. PLT RESULT WAS 416 X 10 TO THE THIRD POWER CELLS/UL. THE HOSPITAL'S RESULTS WERE CONSIDERED CORRECT. ON THE NEXT DAY, THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE FOR HGB AND PLT AND RESULTS WERE: HGB RESULT WAS 9.7G/DL. PLT RESULT WAS 385 X 10 TO THE THIRD POWER CELLS/UL. BASED ON INFORMATION PROVIDED, THERE WAS NO AFFECT TO PATIENT OR USER AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR