MAUDE Adverse Event Report: UNOMEDICAL A/S MIO ADVANCE; UNO INSET II 60/6 PCC PINK MIMX

Model Number	MMT-923
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that patient faced severe hyperglycemia event on 07-jun-2018.The blood glucose level was greater than 600 mg/dl at the time of event with the presence of ketones.The symptoms observed was vomiting.No further information was available.
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 under complaint investigation child record (b)(4).The batch 5218567, in question was manufactured at the reynosa site.Threshold analysis: a query was run on 17-sep-2025 against "final reporting decision equal "serious injury" and "death", "lot number" criteria equal "5218567".The count of complaint is 0 which is below 3.No further statistical trending analysis is required.Device history record (dhr) review: the lot 5218567 was manufactured according to the work instruction (wi) version 77 packaging in the line inset 4, on 11/jan/2018, with a total of (b)(4) units.Review of the dhr showed that a non-conformance nc was opened during the sterilization processes actions were required.Therefore, 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.Test results: no photo was provided.According to the malfunction code, returned samples will not be received due was no specific malfunction to investigate.The reference samples cannot be tested because there was no specific malfunction to investigate.Conclusion summary of complaint investigation: as a result of the following: one nc raised during sterilization process unrelated to complaint code, therefore, 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: MIO ADVANCE
• Common Device Name: UNO INSET II 60/6 PCC PINK MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19686471
• Report Number: 8021545-2024-01839
• Device Sequence Number: 6836148
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• 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): 09/18/2025

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 Expiration Date: 12/10/2020
• Device Model Number: MMT-923
• Device Lot Number: 5218567
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/07/2024
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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