MAUDE Adverse Event Report: MIO¿; INSET II 80/9 PCC GREY

Model Number	MMT-975
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 the united states the patient reported that he faced a bent cannula which led to high blood glucose levels.Further, at 10:00 am, he tried to treat this issue with a correction bolus, as his blood glucose was rising and by afternoon his blood glucose levels were even higher.Moreover because of the stomach flu was going around at work, and with his family, he figured that he was just coming down with something, and his body was just reacting to the illness.Furthermore, when he got home slightly after 1:00 pm, he started throwing up and threw up at least ten times just after midnight.By thursday morning his wife found him on the bathroom floor mostly unresponsive and attempted to get him up, but he yelled at her and told her to leave him alone.Subsequently, his wife called at 911 to be rushed to the emergency room, as the patient experienced diabetic ketoacidosis and his blood glucose level was 950 mg/dl.On (b)(6) 2020, on the day of the incident his blood glucose level was reported to be 850 mg/dl and they transported him to the emergency room, and they found his blood glucose level was 950 mg/dl, so they started giving him insulin intravenously, which took quite a while to get his blood glucose level normalized.The patient was admitted for 3 days in the intensive care unit and 2 days in a regular room.The patient's endocrinologist came in the second day, when he was in the intensive care unit and insisted to pull his infusion set and inspected it, and it turned out that the canula was bent like the letter j but with a sharp bend, not a soft bend, which caused all the extra doses that he gave himself on wednesday and thursday morning to not go inside him.Reportedly, his body mass index was 30.2.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: INSET II 80/9 PCC GREY
• MDR Report Key: 9915183
• Report Number: 3003442380-2020-00230
• Device Sequence Number: 2437803
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 06/01/2022
• Device Model Number: MMT-975
• Device Lot Number: 5284959
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1