BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSOM ULTRA STREP A 25 TEST KIT

    MDR report key: 23357741 · Received October 22, 2025

    Report

    Report Number
    2030538-2025-00002
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    GTY
    UDI-DI
    00742860001475
    PMA / PMN Number
    K992658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR WAS REVIEWED AND THERE ARE NO DEVIATIONS OR IRREGULARITIES NOTED. TWO AVAILABLE RETAIN KITS WERE INSPECTED AND PACKED AS REQUIRED. THE VIALS WERE PROPERLY FILLED WITH AMPOULE, SLEEVE, AND SOLUTION. A VIAL WAS CRUSHED FROM EACH KIT AND NO GLASS POKED THROUGH THE PLASTIC. THE ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    WHEN TRYING TO BREAK THE REAGENT VIAL PRIOR TO USE (GLASS AMPOULE INSIDE A PLASTIC AMPOULE), IT WAS REPORTED THAT THE GLASS POKED THROUGH THE PLASTIC AND CUT THE USER'S HAND. THERE WAS A SMALL CUT THAT BLED, WHICH WAS TREATED BY FLUSHING WITH WATER. THE INJURED AREA SEEMED TO REACT TO THE CHEMICALS IN THE REAGENTS, AND SHE ENDED UP WITH SWELLING, BRUISING, AND PAIN. THE USER WENT TO URGENT CARE AT THE END OF THE DAY AND WAS PRESCRIBED AN ANTIBIOTIC, DOXYCLYCLINE. IT WAS CONFIRMED THAT THERE WAS NO GLASS STUCK IN THE USER'S HAND. IT WAS REPORTED THAT EVERYTHING WAS FINE AND THE ANTIBIOTIC WAS A PREVENTATIVE "JUST IN CASE" TREATMENT FOR THE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243957 OSOM ULTRA STREP A 25 TEST KIT ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY SEKISUI DIAGNOSTICS, LLC 147 241636 00742860001475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention