BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSOM ULTRA STREP A 25 TEST KIT

    MDR report key: 23357740 · Received October 22, 2025

    Report

    Report Number
    2030538-2025-00003
    Event Type
    Malfunction
    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
    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, RESULTING IN A SCRATCH WITHOUT BLOOD. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO TREATMENT PERFORMED OUTSIDE OF BASIC FIRST AID (FLUSH/RINSE AREA FOR 15 MINUTES AND APPLY BANDAGE/BAND AID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243956 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