BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO SHIGELLA ANTISERUM POLY GROUP A

    MDR report key: 11879165 · Received May 25, 2021

    Report

    Report Number
    1025402-2021-00004
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 5, 2021
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    GNB
    UDI-DI
    00382902283416
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ SHIGELLA ANTISERUM POLY GROUP A ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE IS NO AGGLUTINATION FOR S. DYSENTERIAE SEROGROUP 3 WHEN USING CAT 228341 LOT 9354479. CUSTOMER PROBLEM: CUSTOMER REPORTS NO AGGLUTINATION FOR S. DYSENTERIAE SEROGROUP 3 WHEN USING CAT 228341 LOT 9354479. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778359 BD DIFCO SHIGELLA ANTISERUM POLY GROUP A ANTISERA, ALL TYPES, SHIGELLA SPP. GNB LEE LABORATORIES, INC. 228341 9354479 00382902283416

    Patients

    Seq Age Sex Outcome Treatment
    1