MAUDE Adverse Event Report: MIO; INSET II 60/6 PCC BLUE

Model Number	MMT-943
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's mother reported that her daughter experienced nausea, vomiting, abdominal pain, difficulty in breathing and high blood glucose level.They tried to treat it with 20 units of insulin through the pump and went to bed, but the blood glucose level went up to 300 mg/dl, and then to 429 mg/dl, then 678 mg/dl.Further, the infusion was last changed on (b)(6) 2020.Subsequently, on (b)(6) 2020 at 06:00 am, the patient visited the emergency room and consequently, she was admitted to the hospital in the intensive care unit, with blood glucose level higher than 600 mg/dl and diabetic ketoacidosis.During hospitalization, the patient received an insulin drip as corrective treatment and took her insulin pump off.Next morning ((b)(6) 2020), patient's blood glucose level was at 138 mg/dl and she was still in the intensive care unit.They put her insulin pump back on her and the next thing she was back up to 300 mg/dl.After, staying for 17 hours in the hospital, when the patient came home, she changed her site, and found that there was a kink in the cannula.Therefore, she took her old site out and put a new one in.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 60/6 PCC BLUE
• MDR Report Key: 10199923
• Report Number: 3003442380-2020-00310
• Device Sequence Number: 2234187
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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 Model Number: MMT-943
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1