MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MCAN

Model Number	MMT-921A600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2022, the patient reported that she is pregnant, and her infusion set's site was not sticking.Therefore, the infusion set's site was leaking, and the site location was patient's lower back.Her blood glucose level was within range.This issue occurred with eight infusion sets.Moreover, the infusion set had been used for four days.Reportedly, there was no stress or pull on the infusion set.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16047294
• Report Number: 3003442380-2022-01183
• Device Sequence Number: 11985916
• Product Code: FPA
• UDI-Device Identifier: 05705244020214
• UDI-Public: 05705244020214
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2022

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
• Device Expiration Date: 05/01/2024
• Device Model Number: MMT-921A600
• Device Lot Number: 5352659
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/26/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown