BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLLAB 10C M2 CELL TUBE

    MDR report key: 17877375 · Received October 5, 2023

    Report

    Report Number
    1061932-2023-00105
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    UDI-DI
    15099590701505
    PMA / PMN Number
    K183592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D2, PRODUCT CODE - OYE WAS ENTERED WHICH IS A SECONDARY CODE FOR THE CLEARLLAB 10C B CELL TUBES, THE PRIMARY CODE IS PWD, WHICH WAS NOT AN AVAILABLE OPTION FOR THIS FIELD. THERE WERE INTERMITTENT UNEXPECTED CD19+ EVENTS APPEARING IN THE WRONG PLACE WHEN RUNNING CLEARLLAB 10C B CELL TUBE AND CLEARLLAB 10C M2 CELL TUBE. SPECIMENS WITH QUESTIONABLE OR ABNORMAL SCATTER PATTERNS WERE RERUN WITH AN ALTERNATE METHOD. THE BEC FIELD APPLICATION SPECIALIST FOUND THAT THE ISSUE WAS NOT OCCURING ON ALL SAMPLES RUN AND THAT OTHER APPLICATIONS WERE RUNNING WITHOUT ISSUE. TROUBLESHOOTING PERFORMED BY THE CUSTOMER AND THE FIELD APPLICATIONS SPECIALIST INDICATES THAT THERE MAY BE SPECIMEN RELATED IMPACT IN THE PERFORMANCE OF THE ANALYSIS. PER THE PRODUCT SAFETY REFERENCE (PRS) FOR CLEARLLAB REAGENT AND CLEARLLAB 10C PANELS: THESE REAGENTS ARE USED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF HEMATOLOGICALLY ABNORMAL PATIENTS HAVING, OR SUSPECTED OF HAVING, THE SPECIFICALLY IDENTIFIED NEOPLASMS. INTERPRETATION OF THE RESULTS SHOULD BE CONFIRMED BY A PATHOLOGIST OR EQUIVALENT PROFESSIONAL IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS. THE SELECTED REAGENTS ARE INTENDED TO EVALUATE THE IMMUNOPHENOTYPIC PROFILES OF VARIOUS CELL POPULATIONS AS INDICATED FOR SPECIFIC MEDICAL INDICATIONS IN ACCORDANCE WITH THE INTENDED USE OF THE PRODUCT. THEY ARE NOT INTENDED TO PROVIDE INDEPENDENT DETERMINATION FOR THE PRESENCE OR ABSENCE OF SPECIFIC DISEASE BUT RATHER PROVIDE THE CLINICAL PRACTITIONER WITH APPROPRIATE FLOW CYTOMETRIC INFORMATION THAT IN COMBINATION WITH OTHER MODALITIES (CYTOGENETICS, MORPHOLOGICAL EVALUATION, IMMUNOHISTOCHEMISTRY, MOLECULAR STUDIES, PATIENT HISTORY AND PHYSICAL EXAMINATION) CAN BE USED TO REACH A CLINICAL DIAGNOSIS. LABELING: PER THE NAVIOS INSTRUCTIONS FOR USE (PN: A96247AE), THE USER IS INSTRUCTED TO AND/OR ADVISED OF: THERE IS A RISK OF REPORTING INCORRECT RESULTS. DATA DISPLAYS USED TO ARRIVE AT THE TEST RESULT FOR LIGHT SCATTER PATTERNS, ANTIBODY STAINING PROFILES, AND ALL GATES AND BOUNDARIES SHOULD BE REVIEWED BY A LABORATORY PROFESSIONAL WHEN INTERPRETING THE DATA. IF RESULTS ARE SUSPECT, FOLLOW YOUR LABORATORY'S PROCEDURES TO RESOLVE. PER THE CLEARLLAB INSTRUCTIONS FOR USE (PN: C00197): ABNORMAL STATES OF HEALTH ARE NOT ALWAYS REPRESENTED BY ABNORMAL PERCENTAGES OF CERTAIN LEUKOCYTE POPULATIONS. AN INDIVIDUAL IN AN ABNORMAL STATE OF HEALTH MAY SHOW THE SAME LEUKOCYTE PERCENTAGES AS A HEALTHY PERSON. IT IS RECOMMENDED TO USE TEST RESULTS IN CONJUNCTION WITH CLINICAL AND OTHER DIAGNOSTIC DATA. CERTAIN PATIENTS MAY PRESENT UNIQUE PROBLEMS DUE TO ALTERED OR VERY LOW NUMBERS OF CERTAIN CELLULAR POPULATIONS. CUSTOMER TECHNICAL SUPPORT (CTS) PROVIDED REPLACEMENT REAGENT TUBES. THE CUSTOMER TESTED THE NEW LOT AND FOUND THE ISSUE WAS GREATLY IMPROVED. BEC INTERNAL IDENTIFIER - (B)(4). RELATED EVENT - (B)(4), MDR - 1061932-2023-00104.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNEXPECTED CD19+ EVENTS INTERMITTENTLY WHEN RUNNING CLEARLLAB ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER. THE CUSTOMER REPORTED THAT THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH OR IMPACT TO PATIENT TREATMENT OR HEALTH. PATIENT RESULTS WITH QUESTIONABLE AND OR ABNORMAL SCATTER PATTERNS WERE RERUN WITH AN ALTERNATE METHOD. THE ISSUE IS NOT OCCURRING ON ALL SAMPLES. THE OTHER APPLICATIONS ARE RUNNING WITHOUT ISSUE ON THE SAME FLOW CYTOMETER. THE CUSTOMER USES THEIR OWN LABORATORY DEVELOPED SAMPLE PREPARATION PROCEDURE INSTEAD OF THE PROCEDURE IN THE INSTRUCTIONS FOR USE (IFU PN C00197). THE CLEARLAB TUBES WERE RUN ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER: PART NUMBER: BB0910. SERIAL NUMBER: (B)(6). INSTRUMENT UDI: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344621 CLEARLLAB 10C M2 CELL TUBE FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER CLEARLLAB 10C M2 CELL TUBE 240523_02 15099590701505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown