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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in united arab emirates.It was reported that the patient went to an emergency room (er) and eventually got hospitalized on (b)(6) 2025 due to hyperglycemia and ketones event.Blood glucose level was 500 mg/dl at the time of the event.Therefore, patient got treated with intravenous (iv) drip.The duration of hospitalization was less than 24 hours.Patient was found positive for ketones level.Ketones level was more than 1 mg/dl at the time of the event.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united arab emirates.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4 and manufacturing date under h4.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.Complaint investigation results: a complaint investigation has been initiated for record (b)(4) on 07-jul-2025.Device history record (dhr) review: the lot 6004909 was manufactured according to the work instruction (wi) version 66 manufactured in the line 4, on 13/jan/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 were identified; no maintenance events were recorded.Trending: a query was run in database on 07-jul-2025 against harm code untreated diabetic ketoacidosis which the patient is unable to self-manage requiring intervention by a health care professional or requires emergency advance, malfunction code no malfunction describe and lot 6004909 and no more complaint has been registered in database for the same lot, harm code and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production, only one complaint received on the lot in question and harm code, the test on reference samples were not tested since a no malfunction related to the infusion set was reported, therefore no further actions are required.This complaint will not require further root cause investigation nor 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 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; lejre, 4320
• MDR Report Key: 22528106
• Report Number: 3003442380-2025-11642
• Device Sequence Number: 8736522
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-975A
• Device Lot Number: 6004909
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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