MAUDE Adverse Event Report: UNOMEDICAL A/S MIO¿ ADVANCE; UNO INSET II 80/9 PCC GREY MIMX

Model Number	MMT-975
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: (b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On 25-june-2024, it was reported that the patient was hospitalized due to low blood glucose levels.The patient blood glucose levels at time of hospitalization were 20 mg/dl.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
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: electronic quality management system (eqms) search: a query was run in the eqms on 06-jan-2026 against "lot number 5144003 and similar malfunction code malfunction based on complaint information, no malfunction code based on complaint information.The review confirmed that lot 5144003 and the identified failure mode are not associated with any ncrs or corrective and preventive action (capa)s of the same or similar nature.Similar complaints search: a query was run in the eqms on 06-jan-206 against "lot number" criteria equal 5144003 and similar no malfunction based on complaint information, no malfunction code based on complaint information.The count of complaint is 1.The complaint number is (b)(4).Device history record (dhr) review the lot 5144003 was manufactured according to the work instruction (wi) version 23 and manufactured in the l158, on 23-apr-2016, with a total of (b)(4) units.The subassembly gluing tube of lot 5147636 was manufactured according to the wi version 18 and manufactured in the spot04, on 21-apr-2016, with a total of (b)(4) units.The device history record (dhr) was reviewed in accordance with applicable procedures.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that relate to the complaint code.Conclusion: dhr review supports compliance with manufacturing and quality requirements; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Functional testing was not conducted due to the expiration of the batch, which could compromise the integrity and validity of the results.Conclusion: unable to perform visual and fuctional verification; assessment based on available documentation only.Capa determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per wi (monthly trips and alerts).Conclusion summary of complaint investigation: as a result of the following: a comprehensive review was conducted, including eqms queries, similar complaint searches, device history record review, visual evidence assessment, and capa determination.No ncrs or capas of the same or similar nature were found for lot 5144003 and related malfunction codes.One complaint was identified for this lot, but no trend or systemic issue was detected.The manufacturing records confirmed that the lot was produced in compliance with all requirements, with no deviations or maintenance events noted.No photo evidence was provided, so the assessment was based on documentation only.Based on these results, no manufacturing or quality issues were identified, and no further investigation is required.The record will be closed and monitored through routine tracking and trending.

• Brand Name: MIO¿ ADVANCE
• Common Device Name: UNO INSET II 80/9 PCC GREY 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: 19835570
• Report Number: 8021545-2024-02650
• Device Sequence Number: 6648569
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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): 01/06/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/15/2019
• Device Model Number: MMT-975
• Device Lot Number: 5144003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2016
• 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