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).It was reported that the patient faced a bent cannula with four of her infusion sets and due to which she experienced high blood glucose level (yesterday, at 04:30 pm), headache, vomiting, was feeling sick and weak.Therefore, she tried to treat it with manual injection but yesterday ((b)(6) 2021), at 06:00 pm, she ended up in the emergency room due to high blood glucose level of 26.1 mmol/l and she was tested for diabetic ketoacidosis as she had high ketone levels.Reportedly, she just changed the infusion set in the morning, it was used for 8 hours.After staying for six hours in emergency room, the patient was released.She got back with blood glucose level of 14 mmol/l and when she went to bed, her blood glucose went to 21 mmol/l.Therefore, when she removed the infusion set, she noticed that the cannula was bent.Currently, her blood glucose level was 11.7 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
• MDR Report Key: 12360161
• Report Number: 3003442380-2021-00382
• Device Sequence Number: 3736543
• 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

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: 12/01/2023
• Device Model Number: MMT-943A600
• Device Lot Number: 5341383
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/24/2021
• Usage of Device: N
• Patient Sequence Number: 1