MAUDE Adverse Event Report: UNOMEDICAL UM-D MINIMED SURE-T; UNO CONTACT DETACH G29 80/10 SC1 MIMX

Model Number	MMT-866A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: hungary.
Event or Problem Description
Reference number (b)(4).Event occurred in hungary.It was reported that patient faced a crimped infusion set tubing event on (b)(6) 2025 at set connector.The blood glucose level was high and the patient was treated with subcutaneous insulin injection after infusion set change.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The initial mdr with manufacturing report number (3003442380-2025-10324), was submitted on 02-jun-2025.Upon completion of the investigation, the manufacturing date was updated as 28-nov-2024.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 3709030 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 3709030.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6009324, in question was manufactured at the reynosa site.Threshold analysis: a query was run on 19-sep-2025 against "final reporting decision equal "serious injury" and "death", "lot number" criteria equal "6009324".The count of complaint is 0 which is below 3.No further statistical trending analysis is required.Device history record (dhr) review: the lot 6009324 was manufactured according to the work instruction (wi) version 98 and manufactured in the machine multivac 14 on 28/nov/2024, with a total of (b)(4) units.Glue-tubing lot: the lot 4j02646 was manufactured according to the wi version 65 and manufactured in the machine sc02 on 13/sep/2024, 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: one extended was raised during the process unrelated to the malfunction reported, therefore, 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.

• Brand Name: MINIMED SURE-T
• Common Device Name: UNO CONTACT DETACH G29 80/10 SC1 MIMX
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 22139759
• Report Number: 3003442380-2025-10324
• Device Sequence Number: 8205357
• Product Code: FPA
• UDI-Device Identifier: 05705244019461
• UDI-Public: 05705244019461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• 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): 09/20/2025

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
• Device Model Number: MMT-866A
• Device Lot Number: 6009324
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 09/20/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown