MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Model Number	MMT-441AH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: canada.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient went to an emergency room (er) and eventually got hospitalized on (b)(6) 2025 due to hyperglycemia event.Blood glucose level was 80 mg/dl at the time of the event.Patient got treated with insulin via syringes.The duration of hospitalization was for 2 months.Patient was experienced the symptoms of unconscious.Patient was found positive for high ketones level.No further information available.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11.
Additional Manufacturer Narrative
The initial mdr with manufacturing report number (8021545-2025-01511), was submitted on 16-jun-2025.Upon completion of the investigation, the manufacturing date was updated as 30-oct-2023.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 6003789 in question was manufactured at the osted site.Threshold analysis: a query was run on 26-sep-2025 against "final reporting decision equal "serious injury" and "death", "lot number" criteria equal "6003789".The count of complaint is 1 which is below 3 so no further statistical trending analysis is required.Device history record (dhr) review: the lot 6003789 was manufactured according to work instruction (wi) [79] appendix 1 batchcard for production of packaging room on 30-oct-2023, 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 was identified, nor maintenance events were recorded related to complaint code.Test results: no sample was provided.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no trend identified, 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.

• Brand Name: MEDTRONIC EXTENDED
• Common Device Name: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, mexico 4320
• MDR Report Key: 22208876
• Report Number: 8021545-2025-01511
• Device Sequence Number: 20872599
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• 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): 09/26/2025

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
• Device Expiration Date: 09/01/2025
• Device Model Number: MMT-441AH
• Device Lot Number: 6003789
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown