MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 60/6 SC1 PINK MIMX

Model Number	MMT-923A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country : australia.
Event or Problem Description
Reference number (b)(4).Event occurred in australia.On (b)(6) 2024, it was reported that patient faced infusion set leakage at site event.The blood glucose was reported 15.9 mmol/l.Moreover, the patient had been using the insulin pump system within 48 hours of reported low blood glucose event.No further information available.
Additional Manufacturer Narrative
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.The complaint (b)(4) has been evaluated.The batch 6003872 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instructions (wi) guideline for test of reference samples version 11 for the malfunction leakage (source/cause cannot be identified, only use when a specific malfunction cannot be determined) complaint investigations.Photo/sample was not provided.To test the product, the reference samples from the lot have been requested.The following test was performed: visual test according to (version 41) criterios de calidad para productos de la familia inset eng-esp.Docx - (version18) acceptance criteria for the spot curing process.Doc test on returned reference samples, 10 samples out 10 samples passed the test.Functional test 1 according to (version10) flow test on customer complaints - pruebas de flujo en quejas del cliente.Doc test on returned reference samples, 10 samples out 10 samples passed the test.Functional test 2 according to (version 25) instrucciones para el uso del equipo de fuga en el area de inspeccion.Doc test on returned reference samples, 10 samples out 10 samples passed the test.A batch record review was conducted resulting in the following: the lot 6003872 was manufactured according to the document version 85 on the packing process in the line 6, on 17/oct/2023, with a total of (b)(4) units.Review of the device history report (dhr) showed that all relevant tests required during the related process had been fulfilled and met the requirements.Conclusion summary of the related event: as a result of the following: no reported harm, no defect on test, no raised during production.No further actions are required.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19956991
• Report Number: 3003442380-2024-20626
• Device Sequence Number: 8897372
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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): 09/25/2024

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 Expiration Date: 09/15/2026
• Device Model Number: MMT-923A
• Device Lot Number: 6003872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native