BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5

    MDR report key: 22627903 · Received July 28, 2025

    Report

    Report Number
    1025402-2025-00003
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 25, 2025
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    GRM
    UDI-DI
    00382902247517
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO RETURNS WERE RECEIVED TO INVESTIGATE THIS COMPLAINT. THE INVESTIGATION BEGAN WITH UNDERSTANDING THE ENTRY DESCRIPTION PROVIDED TO THE CUSTOMER INTAKE REPRESENTATIVE. FROM THE HAZARD DESCRIBED TO CUSTOMER SERVICE, THE CUSTOMER RECEIVED A FALSE POSITIVE REACTION WITH MONOPHASIC STRAINS OF SALMONELLA TYPIMURIUM. TO INVESTIGATE THE COMPLAINT ON CATALOG: 224751, LOT: 4011976 THE RETAINED SAMPLE OF THE COMPLAINT LOT WAS TESTED ACCORDING TO THE PRODUCTS INSTRUCTIONS FOR USE. THE ANTISERUM WAS REHYDRATED AND TESTED WITH TWO HETEROLOGOUS TEST PANELS AT THE ROUTINE TEST DILUTION OF 1:500. NO CROSS REACTIONS WERE OBSERVED WITH STRAINS TYPHIMURIUM FACTOR I AND RUBISLAW FACTOR R AT 1:500 DILUTION. BASED ON THE TESTING PERFORMED, THE COMPLAINT WAS NOT CONFIRMED. TO FURTHER INVESTIGATE, THE BATCH HISTORY RECORD FOR THE COMPLAINT LOT WAS REVIEWED AND FOUND TO BE SATISFACTORY. PREVIOUS COMPLAINTS RECEIVED ON THE PRODUCT LINE WERE REVIEWED COVERING A THREE-YEAR PERIOD. DURING THE REVIEW PERIOD NO OTHER COMPLAINTS WERE RECEIVED, ON THE COMPLAINTS CATALOG OR LOT NUMBER; BD WILL CONTINUE TO MONITOR TRENDS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5, THERE WAS A FALSE POSITIVE AGGLUTINATION REACTION IN TWO KITS. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5, THERE WAS A FALSE POSITIVE AGGLUTINATION REACTION IN TWO KITS. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652136 BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5 ANTISERA, ALL GROUPS, SALMONELLA SPP. GRM LEE LABORATORIES, INC. 4011976 00382902247517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown