MAUDE Adverse Event Report: UNOMEDICAL UM-D MINIMED SILHOUETTE; UNO COMFORT 80/17 SC1 MINI

Model Number	MMT-384A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/24/2025
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 the patient experienced infusion set tubing had a crack on (b)(6) 2025.It was also reported that the patient was hospitalized on (b)(6) 2025 for less than 24 hours and patient blood glucose levels while admitting the hospital was 474 mg/dl, therefore patient had visited emergency room (er) and received manual injection of insulin.No further information was 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 (b)(4) does not require a complaint that is type 2 reportable to open a child investigation.This child investigation was opened against a previous revision of (b)(4).Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003429, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6003429 was manufactured according to the work instruction (wi) version 15 and packaging in the multivac m10 on 04-oct-2023, with a total of (b)(4) units.The sub-assembly: gluing of tubing of the lot 3j02873 was manufactured according to the wi version 10 and manufactured in the machine lc02, on 24-sep-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 was identified, nor maintenance events were recorded related to complaint code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no trend identified for the lot in question and malfunction 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: MINIMED SILHOUETTE
• Common Device Name: UNO COMFORT 80/17 SC1 MINI
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21916247
• Report Number: 3003442380-2025-07221
• Device Sequence Number: 15727381
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• 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): 09/08/2025

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: 09/02/2026
• Device Model Number: MMT-384A
• Device Lot Number: 6003429
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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