BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4

    MDR report key: 11401353 · Received March 2, 2021

    Report

    Report Number
    1025402-2021-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    February 3, 2021
    Report Date
    June 22, 2021
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    GSH
    UDI-DI
    00382902230212
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: RETURN SAMPLES DO NOT APPLY; THIS COMPLAINT WAS INITIATED BASED ON INTERNAL TESTING OF THE PRODUCT, PERFORMED BY BD. TO INVESTIGATE THE COMPLAINT, A RETAINED SAMPLE OF THE LOT WAS TESTED, PER THE PRODUCT PACKAGE INSERT, WITH MULTIPLE LOTS OF LISTERIA O ANTIGEN TYPE 1 (SLIDE), ONE OF THE QC ANTIGENS FOR THE PRODUCT, ALSO MANUFACTURED AT BD GRAYSON. THE RETAINED VIAL OF ANTISERUM DEMONSTRATED NEGATIVE REACTIONS AT 2 MINUTES WITH THESE QC ANTIGEN LOTS. TO FURTHER INVESTIGATE THE ISSUE, THE ANTISERUM WAS ALSO TESTED WITH SEVERAL CULTURES REPRESENTING LISTERIA MONOCYTOGENES TYPE 1 (TYPE 1/2A AND TYPE 1/2B CULTURE STRAINS WERE USED IN THIS TESTING). REACTIONS OBSERVED WITH THE CULTURES TESTED RANGED FROM NEGATIVE TO 3+. THE COMPLAINT WAS CONFIRMED BASED ON THESE RESULTS. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY; NO QUALITY NOTIFICATIONS WERE ISSUED FOR THIS BATCH. THE COMPLAINT WAS CONFIRMED. CAPA INITIATION DETERMINATION (CID) (B)(4) WAS COMPLETED ON 02/08/2021. BASED ON THE CID, THE TEAM DECISION WAS TO INITIATE A CAPA. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING BENCH TESTING WITH BD DIFCO¿; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4 A WEAK REACTION WAS OBSERVED WITH 4 VIALS. RESULTS WERE NOT REPORTED THERE WAS NO REPORT OF PATIENT IMPACT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING BENCH TESTING WITH BD DIFCO¿; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4 A WEAK REACTION WAS OBSERVED WITH 4 VIALS. RESULTS WERE NOT REPORTED THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299475 BD DIFCO; LISTERIA O ANTISERUM POLY SEROTYPES 1, 4 ANTISERA, ALL TYPES, LISTERIA MONOCYTOGENES GSH LEE LABORATORIES, INC. 223021 9200273 00382902230212

    Patients

    Seq Age Sex Outcome Treatment
    1