MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED MIO; UNO INSET II 80/9 SC1 GREY MIMX

Model Number	MMT-975A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in the united arab emirates.It was reported that the patient got hospitalized on (b)(6)2025 due to bent cannula leading to hyperglycemia.The blood glucose level was 400 mg/dl at the time of event and the patient got treated with insulin pen and solution.Company do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united arab emirates.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY MIMX
• 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; reynosa , tamps., lejre 4320
• MDR Report Key: 22068767
• Report Number: 3003442380-2025-09298
• Device Sequence Number: 8766534
• Product Code: FPA
• UDI-Device Identifier: 05705244020184
• UDI-Public: 05705244020184
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-975A
• Device Lot Number: 6003343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown