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

Lot Number	5255825
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
(b)(4).Event occurred in the united states.On (b)(6) 2019, it was reported by a nurse that she has a patient who was admitted to the hospital, in the afternoon of (b)(6) 2019, due to kinked cannula, diabetic ketoacidosis, gastric pains and wore a pump.The nurse noticed that the patient's cannula was kinked upon removal which led to increased blood glucose levels.She received some unspecified medications to correct the insulin.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: 8939124
• Report Number: 3003442380-2019-01743
• Device Sequence Number: 2521436
• 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 Expiration Date: 09/01/2021
• Device Lot Number: 5255825
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1