BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM

    MDR report key: 11207364 · Received January 21, 2021

    Report

    Report Number
    3007886372-2021-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    MVU
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM THERE IS NO SIGNAL FOR KAPPA AND CD23. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS NO SIGNAL FOR KAPPA AND CD23 IN SOME LYOTUBES. ADDITIONALLY, ON 202-01-08 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. WHAT IS THE IMPACTED 624777 BATCH/LOT NUMBER? 0163232. 2. WHEN WAS THIS COMPLAINT BATCH FIRST USED BY THE LAB? APPEARS THAT THERE ARE INTERMITTENT POUCHES/BAGS THAT ARE AFFECTED AND NOT ENTIRE BATCH. 3. WHAT IS THE 624774 BATCH NUMBER THAT WAS USED AS THE CONTROL? 4. DO YOU HAVE ANY DATA SHOWING AN ALTERNATE BATCH OF 624777 THAT IS PERFORMING DIFFERENTLY FROM THE COMPLAINT BATCH ON THE SAME SAMPLE? HAVE YOU RUN AN ALTERNATE 624777 BATCH AS A CONTROL? -YES, WILL LOCATE AND SEND. 5. IS PATIENT DATA OR DIAGNOSIS IMPACTED IN ANY WAY? YES TO DATA, NOT TO DIAGNOSIS 6. IS THE CD19 NO SIGNAL REPEATABLE ACROSS MULTIPLE POUCHES, INSTRUMENTS, TECHNICIANS AND SAMPLES? YES. G.4. DATE RECEIVED BY MANUFACTURER: 2021-01-08.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM THERE IS NO SIGNAL FOR KAPPA AND CD23. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS NO SIGNAL FOR KAPPA AND CD23 IN SOME LYOTUBES. ADDITIONALLY, ON 202-01-08 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. WHAT IS THE IMPACTED 624777 BATCH/LOT NUMBER? 0163232. 2. WHEN WAS THIS COMPLAINT BATCH FIRST USED BY THE LAB? APPEARS THAT THERE ARE INTERMITTENT POUCHES/BAGS THAT ARE AFFECTED AND NOT ENTIRE BATCH. 3. WHAT IS THE 624774 BATCH NUMBER THAT WAS USED AS THE CONTROL? 4. DO YOU HAVE ANY DATA SHOWING AN ALTERNATE BATCH OF 624777 THAT IS PERFORMING DIFFERENTLY FROM THE COMPLAINT BATCH ON THE SAME SAMPLE? HAVE YOU RUN AN ALTERNATE 624777 BATCH AS A CONTROL? YES, WILL LOCATE AND SEND. 5. IS PATIENT DATA OR DIAGNOSIS IMPACTED IN ANY WAY? YES TO DATA, NOT TO DIAGNOSIS 6. IS THE CD19 NO SIGNAL REPEATABLE ACROSS MULTIPLE POUCHES, INSTRUMENTS, TECHNICIANS AND SAMPLES? YES.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM THERE IS NO SIGNAL FOR KAPPA AND CD23. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS NO SIGNAL FOR KAPPA AND CD23 IN SOME LYOTUBES. WHAT IS THE IMPACTED 624777 BATCH/LOT NUMBER? 0163232. WHEN WAS THIS COMPLAINT BATCH FIRST USED BY THE LAB? APPEARS THAT THERE ARE INTERMITTENT POUCHES/BAGS THAT ARE AFFECTED AND NOT ENTIRE BATCH. WHAT IS THE 624774 BATCH NUMBER THAT WAS USED AS THE CONTROL? DO YOU HAVE ANY DATA SHOWING AN ALTERNATE BATCH OF 624777 THAT IS PERFORMING DIFFERENTLY FROM THE COMPLAINT BATCH ON THE SAME SAMPLE? HAVE YOU RUN AN ALTERNATE 624777 BATCH AS A CONTROL? -YES, WILL LOCATE AND SEND. IS PATIENT DATA OR DIAGNOSIS IMPACTED IN ANY WAY? YES TO DATA ¿ NOT TO DIAGNOSIS IS THE CD19 NO SIGNAL REPEATABLE ACROSS MULTIPLE POUCHES, INSTRUMENTS, TECHNICIANS AND SAMPLES? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108331 PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM NA MVU BECTON, DICKINSON AND CO. 0163232

    Patients

    Seq Age Sex Outcome Treatment
    1