BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLLAB 10C B CELL TUBE

    MDR report key: 13902717 · Received March 25, 2022

    Report

    Report Number
    1061932-2022-00020
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 25, 2022
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    OYE
    UDI-DI
    15099590701475
    PMA / PMN Number
    K183592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE - NAVIOS FLOW CYTOMETRY INSTRUMENT CODE 'OYE' WAS POPULATED IN FIELD BECAUSE THE CORRECT PRODUCT CODE OF 'PWD' WOULD NOT POPULATE IN THE RESPECTIVE FIELD LABELING: PER THE CLEARLLAB SYSTEM GUIDE (PN: C24688) THE USER IS INSTRUCTED AND/OR ADVISED THAT: DUE TO THE NATURE OF MULTI-COLOR FLOW CYTOMETRY AND SPECIMEN VARIABILITY, SOME ANTIGEN/FLUORESCENT MARKER COMBINATIONS EXHIBIT SPREADING, WHICH INCREASES SIGNAL SPILLOVER INTO OTHER CHANNELS. TRAINED OPERATORS MUST DETERMINE THAT THE FLUORESCENT COMPENSATION AND GATING ARE APPROPRIATE. ALL DATA PLOTS AND HISTOGRAMS MUST BE REVIEWED BEFORE RESULTS ARE REPORTED TO ENSURE ANALYSIS WAS PERFORMED CORRECTLY. A REVIEW OF ALL DATA PLOTS FOR THE PRESENCE OF THE EXPECTED STAINING PATTERNS IS RECOMMENDED FOR ALL SAMPLES. BEC INTERNAL IDENTIFIER (B)(4).

    Description of Event or Problem · 0

    WE ARE USING CLEARLLAB 10C FOR CHARACTERIZATION B CELLS LEUKEMIA. CD38 MARKER IS DETECTED IN THE CHANNEL APC-AF700. WHEN WE SETUP THE COMPENSATION WITH THE PARAMETERS DEFINED BY MANUFACTUR THE SIGNAL IN CD38 APC AF700 IS SO HIGH AND THE EVENTS ARE SHOWN IN THE EXTREM E RIGHT AXIS. WE DETECT A SPECTRAL SPILLOVER BECAUSE THE PLASMA CELLS ARE POSITIVE IN THE NEXT CHANNEL WITH THE MARKER CD20 APC AF750. ERRONEOUS PATIENT RESULTS WERE GENERATED BUT WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THE CUSTOMER CONSIDERED THE RESULTS TO BE ERRONEOUS AND REPEATED THE TESTS USING LIQUID REAGENT TO OBTAIN ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054740 CLEARLLAB 10C B CELL TUBE FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER IRELAND INC. CLEARLLAB 10C B CELL TUBE 081120_44 15099590701475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown