BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 545606 · Received March 26, 2004

    Report

    Report Number
    1061932-2004-00003
    Event Type
    Other
    Date Received
    March 26, 2004
    Date of Event
    February 23, 2004
    Report Date
    March 26, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO OUR CUSTOMER, WHEN RUNNING THE LH750 IN MANUAL MODE AND USING A PRE-DILUTION FACTOR (FOR THIS EVENT, THE CUSTOMER MANUALLY PRE-DILUTED SAMPLE B BY 1:2), THE SAMPLE PRIOR (SAMPLE A) TO THE MANUALLY DILUTED SAMPLE (SAMPLE B) WAS MULTIPLIED BY A FACTOR OF 2. AS A RESULT, BOTH SAMPLE A AND SAMPLE B HAD THEIR CBC PARAMETERS MULTIPLIED BY 2 (SEE B6), INSTEAD OF ONLY BEING APPLIED TO SAMPLE B. THIS PRE-DILUTION WAS PERFORMED OFF-LINE AND A MULTIPLICATION FACTOR OF 2 WAS ENTERED INTO THE WORKSTATION WHILE SAMPLE A WAS BEING ANALYZED BY THE LH750. THE RESULTS FOR SAMPLE A WERE FLAGGED BY THE INSTRUMENT THAT IT HAD BEEN MULTIPLIED BY A FACTOR OF 2. THE CUSTOMER CAUGHT THE ERRONEOUS PARAMETERS BASED ON THE INSTRUMENT FLAGGING. INSTRUMENT FLAGGING OPERATED PER DESIGN. RESULTS FOR SAMPLE B WERE NOT FLAGGED BY THE INSTRUMENT. THE CUSTOMER INDICATED THAT PT TREATMENT WAS NOT AFFECTED BY THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750, SOFTWARE REV. 2B1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other