BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS&T IVD BEADS 50TEST

    MDR report key: 11457243 · Received March 10, 2021

    Report

    Report Number
    2916837-2021-00078
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 9, 2021
    Report Date
    March 16, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THIS IS NOT A REPORTABLE EVENT. INCORRECT RESULTS ON INSTRUMENT SET UP IS NOT CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE CS&T IVD BEADS 50 TEST THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CS&T IVD BEADS 50 TEST FALSE POSITIVE. STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POSITIVE AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWS THAT MAJORITY OF THE POI IS HAVING CYCD3-.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE CS&T IVD BEADS 50 TEST THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CS&T IVD BEADS 50 TEST FALSE POSITIVE. STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POSITIVE AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWS THAT MAJORITY OF THE POI IS HAVING CYCD3-."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354554 CS&T IVD BEADS 50TEST NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 0065086

    Patients

    Seq Age Sex Outcome Treatment
    1