MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS, LLC OSOM ULTRA STREP A 25 TEST KIT; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number	147
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: OSOM ULTRA STREP A 25 TEST KIT
• Common Device Name: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): SEKISUI DIAGNOSTICS, LLC; 6659 top gun st; san diego CA 92121
• Manufacturer (Section G): SEKISUI DIAGNOSTICS, LLC; one wall street; burlington MA 01803
• Manufacturer Contact: rob bombard ; one wall street; burlington, MA 01803
• MDR Report Key: 23357741
• Report Number: 2030538-2025-00002
• Device Sequence Number: 18367690
• Product Code: GTY
• UDI-Device Identifier: 00742860001475
• UDI-Public: 00742860001475
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K992658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 147
• Device Lot Number: 241636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown