MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MCAN

Model Number	MMT-943A600
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, it was reported that when the patient woke up, he experienced chest pain, headache, disorientation, body cramped and was throwing up (high blood glucose level).The patient stated when he removed the infusion set the cannula was found to be bent and he faced this issue with five infusion sets when he removed them.Moreover, the infusion set had been used since (b)(6) 2022 and the site location was patient's buttock.Recently, his high blood glucose level event began on (b)(6) 2022 and subsequently, at 11:00 am, he was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 26 mmol/l.During hospitalization, he received insulin via intravenous route as corrective treatment.Currently, the patient was in the hospital and his blood glucose level was 13 mmol/l.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13410802
• Report Number: 3003442380-2022-00226
• Device Sequence Number: 3871859
• Product Code: FPA
• UDI-Device Identifier: 05705244020337
• UDI-Public: 05705244020337
• 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
• Report Date (Section B): 02/01/2022

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
• Device Expiration Date: 12/01/2022
• Device Model Number: MMT-943A600
• Device Lot Number: 5304727
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/01/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown