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

Lot Number	UNKNOWN
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.A (b)(6) patient reported multiple bent cannula issues, as the insulin was flowing freely with the pump and did multiple set changes, but still nothing was working.Moreover, when the set was changed, the cannula was found bent.However, after the patient woke up from a nap, trying not to vomit but experienced diabetic ketoacidosis due to another bent site.On (b)(6) 2019 (friday night), the patient was admitted in the intensive care unit, in full blown diabetic ketoacidosis.During hospitalization, the patient was put on an insulin drip, intravenous fluids (drug name unknown), had countless blood investigations, three intravenous, and more blood glucose tests.Further, the patient was doing well finally, enough to go back on the pump on the day of this report, dated (b)(6) 2019) and ate for the first time since early friday after inserting a new set and did a bolus.Reportedly, the patient was in the intensive care unit for three days and was still admitted at the time of this report ((b)(6) 2019).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 PINK
• MDR Report Key: 9138403
• Report Number: 3003442380-2019-01824
• Device Sequence Number: 3123209
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1