MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 GREY MCAN

Model Number	MMT-965A600
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Event occurred in (b)(6).On (b)(6) 2020, the patient's mother reported that her son experienced high blood glucose levels (one month ago (b)(6) 2020 and again yesterday on (b)(6) 2020 (17 mmol/l).On (b)(6) 2020, the infusion set was inserted.Reportedly, the infusion sets did not stick (adhesion problems).At the time of the incident his blood glucose level was 24 mmol/l, which they treated with the needle.The patient's mother mentioned that sets were stored in the bathroom rather than in kitchen to try to make sure ambient temperature in room was not too warm.Currently, his blood glucose level was 10 mmol/l and felt good.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 GREY MCAN
• MDR Report Key: 11768298
• Report Number: 3003442380-2021-00236
• Device Sequence Number: 11539307
• Product Code: FPA
• UDI-Device Identifier: 05705244020399
• UDI-Public: 05705244020399
• Combination Product (Y/N): Y
• 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

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: No Information
• Device Expiration Date: 12/01/2022
• Device Model Number: MMT-965A600
• Device Lot Number: 5304728
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1