MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 80/6 PCC GREY MCAN

Model Number	MMT-965600
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number: (b)(4).Event occurred in canada.It was reported that the patient was hospitalized on 13-oct due to high blood glucise level and reported issue with the pump.No further information available.
Additional Manufacturer Narrative
Patient city: (b)(6).Patient country: (b)(6).

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 PCC GREY MCAN
• 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: 20682539
• Report Number: 3003442380-2024-31131
• Device Sequence Number: 18282060
• Product Code: FPA
• UDI-Device Identifier: 05705244007819
• UDI-Public: 05705244007819
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: 04/08/2020
• Device Model Number: MMT-965600
• Device Lot Number: 5187542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown