BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7

    MDR report key: 23383833 · Received October 24, 2025

    Report

    Report Number
    1025402-2025-00011
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 17, 2025
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    GRM
    UDI-DI
    00382902281610
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO RETURN SAMPLES WERE RECEIVED TO INVESTIGATE THIS COMPLAINT. TO INVESTIGATE THE COMPLAINT ON CATALOG 228161, LOT 4270060, ACCORDING TO THE PRODUCTS INSTRUCTIONS FOR USE, USING AVAILABLE CULTURE REPRESENTING SALMONELLA O ANTISERUM FACTOR 7 GROUP C1. FOR THE ANTISERUM TEST, A PORTION OF THE CULTURE WAS REMOVED FROM THE AGAR PLATE AND MIXED INTO ONE DROP OF ANTISERUM ON A SLIDE. IN ADDITION, THE CULTURE WAS TESTED IN A DROP OF SALINE TO CHECK FOR ROUGHNESS. EACH SLIDE WAS ROTATED FOR ONE MINUTE BEFORE READING THE REACTION. RESULTS WERE AS FOLLOWS: 4+ REACTIONS WERE OBSERVED AT UNDILUTED. NO REACTIVITY WAS OBSERVED WHEN THE CULTURE WAS TESTED IN SALINE. BASED ON THE TESTING PERFORMED THE COMPLAINT WAS NOT CONFIRMED. TO FURTHER INVESTIGATE THE BATCH HISTORY RECORD OF THE PRODUCT LOT WAS REVIEWED. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES, AND ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE ALSO REVIEWED COVERING A THREE-YEAR PERIOD. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THE LOT NUMBER IN THE PERIOD REVIEWED.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED WHILE USING THE ANTISERA, ALL GROUPS, SALMONELLA SPP. AN UNSPECIFIED NUMBER OF PATIENT SAMPLES FAILED TO AGGLUTINATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE ANTISERA, ALL GROUPS, SALMONELLA SPP. AN UNSPECIFIED NUMBER OF PATIENT SAMPLES FAILED TO AGGLUTINATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790127 BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7 ANTISERA, ALL GROUPS, SALMONELLA SPP. GRM LEE LABORATORIES, INC. 4270060 00382902281610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown