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

Model Number	MMT-886A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city:(b)(6).Patient country: germany.H11: since no lot number is available.A detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends picked up, this would flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in germany.It was reported that the patient faced insulin flow blockage event on (b)(6) 2025 due to blockage in tubing.No further information available.

• 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., 88736 ; MX 88736
• Manufacturer Contact: ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736
• MDR Report Key: 21640651
• Report Number: 3003442380-2025-03793
• Device Sequence Number: 15129971
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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-886A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/19/2025
• 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