BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSDUET SAMPLE PREP

    MDR report key: 11597218 · Received March 31, 2021

    Report

    Report Number
    2916837-2021-00124
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 8, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR# 2916837-2021-00124 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE RUNNING PATIENT SAMPLES WITH BD FACSDUET¿ SAMPLE PREP THE LABELING OF THE ILT PANEL ARE INACCURATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I WOULD LIKE TO CONTACT YOU TO TELL YOU ABOUT A MARKING DYSFUNCTION WHICH SEEMS TO BE REPEATING ITSELF. INDEED, IT HAPPENS ON SOME PATIENTS PREPARED BY THE DUET, THAT THE LABELING OF THE ILT PANEL IS ERRONEOUS WITH SYSTEMATICALLY THE SAME PROBLEMS OBSERVED: ABSENCE OF CD3- CELLS AND INCREASE IN THE PROPORTION OF DOUBLE-NEGATIVE CD3 + CELLS. CD3 + MARKING IN GENERAL STRONG. THESE PROBLEMS ARE RESOLVED AFTER NEW ASSEMBLY (THE STRETCHED ASPECT OF LY TCD4 + IS NOT SYSTEMATIC) FORTUNATELY, THE VIGILANCE OF TECHNICIANS AND INTERNS MADE IT POSSIBLE EACH TIME NOT TO GIVE ERRONEOUS RESULTS. DO YOU KNOW WHAT COULD BE THE CAUSE OF THIS MALFUNCTION?

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE RUNNING PATIENT SAMPLES WITH BD FACSDUET" SAMPLE PREP THE LABELING OF THE ILT PANEL ARE INACCURATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: I WOULD LIKE TO CONTACT YOU TO TELL YOU ABOUT A MARKING DYSFUNCTION WHICH SEEMS TO BE REPEATING ITSELF. INDEED, IT HAPPENS ON SOME PATIENTS PREPARED BY THE DUET, THAT THE LABELING OF THE ILT PANEL IS ERRONEOUS WITH SYSTEMATICALLY THE SAME PROBLEMS OBSERVED: ABSENCE OF CD3- CELLS AND INCREASE IN THE PROPORTION OF DOUBLE-NEGATIVE CD3 + CELLS. CD3 + MARKING IN GENERAL STRONG. THESE PROBLEMS ARE RESOLVED AFTER NEW ASSEMBLY (THE STRETCHED ASPECT OF LY TCD4 + IS NOT SYSTEMATIC) FORTUNATELY, THE VIGILANCE OF TECHNICIANS AND INTERNS MADE IT POSSIBLE EACH TIME NOT TO GIVE ERRONEOUS RESULTS. DO YOU KNOW WHAT COULD BE THE CAUSE OF THIS MALFUNCTION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497766 BD FACSDUET SAMPLE PREP NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1