MAUDE Adverse Event Report: UNOMEDICAL UM-D QUICK SET PARADIGM; UNO QUICK-SET 60/6 PCC 2-PACK ECA

Model Number	MMT-399T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in israel.It was reported that the patient experienced an event of low blood glucose resulting in hospitalization on (b)(6) 2025.Length of hospitalization was greater than 24 hours.Treatment for low blood glucose was using syringe to increase sugar.No further information available.
Additional Manufacturer Narrative
E1 : (b)(6).Patient country : israel.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted medical device problem code under h6.Unomedical hereby submits this supplemental report as part of its complaint remediation activities conducted under a capa/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: upon review of the event description and assigned malfunction insulin overdosing due to priming set up not followed, it has been determined that the complaint does not allege a product malfunction has occurred.Additional information was requested; however, a lot number or any product specific information was not provided.No device, device components, or other visual or physical evidence was made available for evaluation.Consequently, visual inspection, retain-sample testing, or the assessment of potential product performance issues, component integrity, or manufacturing defects could not be performed.Therefore, no additional investigation activities were required.Corrective and preventive action (capa) determination based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Complaint investigation - conclusion: based on the event description, assigned malfunction code, and limited information available, the reported failure could not be confirmed for this complaint.

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/6 PCC 2-PACK ECA
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21854093
• Report Number: 3003442380-2025-06395
• Device Sequence Number: 8817712
• Product Code: FPA
• UDI-Device Identifier: 05705244020436
• UDI-Public: 05705244020436
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-399T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown