MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 46/6 SC1 BLUE MIMX

Model Number	MMT-941A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city:(b)(6).Patient country: (b)(6).Since no lot number is availabel, 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 would flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in australia.On (b)(6) 2024, it was reported that the patient encountered infusion set leaks in the tubing site.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20308644
• Report Number: 3003442380-2024-27306
• Device Sequence Number: 15674360
• Product Code: FPA
• UDI-Device Identifier: 05705244020009
• UDI-Public: 05705244020009
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2024

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 Model Number: MMT-941A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/26/2024
• 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
• Patient Sex: Male