MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. QUICK-SET PARADIGM; UNO QUICK-SET 60/6 PCC 2-PACK ECA

Model Number	MMT-399T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in israel it was reported that patient faced infusion set cannula break event on (b)(6) 2024.The infusion set was in use for one day.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
E1:patient city: (b)(6).Patient country: israel h11: since no lot number is available, a detailed investigation, tests or reference samples or batch review cannot be concluded.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/6 PCC 2-PACK ECA
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 22333921
• Report Number: 3003442380-2025-11017
• Device Sequence Number: 8993847
• Product Code: FPA
• UDI-Device Identifier: 05705244020436
• UDI-Public: 05705244020436
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K070430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: Lay User/Patient
• Device Model Number: MMT-399T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown