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 Code	Laceration(s) (1946)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
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, 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).

• 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: 23357740
• Report Number: 2030538-2025-00003
• Device Sequence Number: 8900000
• 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?: No
• 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
• Patient Sex: Unknown