MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; UNO COMFORT SHORT 60/13 PCC MINI

Model Number	MMT-381
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united states.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced occlusion at the tubing event on (b)(6) 2024.Patient changed supplies as necessary and resumed insulin therapy.No further information available.
Additional Manufacturer Narrative
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.Revision 21 of procedure (b)(4), a child investigation is not required to document the device history record (dhr) review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6000120, in question was manufactured at the reynosa site.Dhr review: the lot 6000120 was manufactured according to the work instruction (wi) version 14 and manufactured in the machine multivac 10 on 10/mar/2023, with a total of (b)(4) units.Glue-tubing lot: the lot 4c00324 was manufactured according to the wi version 61 and manufactured in the machine sc05 and sc06 on 08/mar/2024, with a total of (b)(4) units.Glue-tubing lot: the lot 3c01167 was manufactured according to the wi version 50 and manufactured in the machine lc02 on 10/mar/2023, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified related to the malfunction reported, no maintenance events were recorded.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT SHORT 60/13 PCC MINI
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20862391
• Report Number: 3003442380-2024-13211
• Device Sequence Number: 12917333
• Product Code: FPA
• UDI-Device Identifier: 05705244008588
• UDI-Public: 05705244008588
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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 Expiration Date: 02/06/2026
• Device Model Number: MMT-381
• Device Lot Number: 6000120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2024
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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