MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMED MIO ADVANCE; MIO ADV. GREY 60/6 PCC INT

Model Number	MMT-242
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	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: the united states.H11: since no lot number is available, a detailed investigation, tests or reference samples or batch review cannot be concluded.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient was hospitalized (b)(6) 2025 due to hyperglycemia.The blood glucose level was 415 mg/dl at the time of event and the patient got treated with insulin injection.No further information available.

• Brand Name: MINIMED MIO ADVANCE
• Common Device Name: MIO ADV. GREY 60/6 PCC INT
• 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: 22528077
• Report Number: 8021545-2025-01811
• Device Sequence Number: 12948052
• Product Code: FPA
• UDI-Device Identifier: 05705244016323
• UDI-Public: 05705244016323
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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-242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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