MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC PINK

Lot Number	5230058
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 she was not receiving insulin due to a bent cannula which led to high blood glucose level and diabetic ketoacidosis.The patient's blood glucose level was 900 mg/dl when she was admitted in the hospital.She stayed in the icu for a week and was treated with manual injections.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 80/6 PCC PINK
• MDR Report Key: 8431229
• Report Number: 3003442380-2019-00593
• Device Sequence Number: 1062948
• Product Code: FPA
• UDI-Device Identifier: 05705244007871
• UDI-Public: 05705244007871
• 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: 03/01/2021
• Device Lot Number: 5230058
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1