MAUDE Adverse Event Report: INSET¿; INSET I 60/9 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.The patient faced kinked cannula issue after the removal of the set.Reportedly the blood glucose level of the patient was 800 mg/dl and had positive and large ketones.She was confused which was a symptom of her high blood glucose levels.Subsequently, she was hospitalized and received insulin as corrective treatment.She remained on the pump and was hospitalized for three days.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: INSET¿
• Common Device Name: INSET I 60/9 PINK
• MDR Report Key: 8538426
• Report Number: 3003442380-2019-01290
• Device Sequence Number: 16221641
• Product Code: FPA
• UDI-Device Identifier: 05705244006942
• UDI-Public: 05705244006942
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: 02/21/2017
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1