MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY

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 reported that the infusion set cannula was bent.Reportedly, the patient had high blood glucose levels and experienced diabetic ketoacidosis, which was self-treated with a correction bolus via the pump.Subsequently, the patient received intravenous insulin drip and some unspecified fluids as corrective treatment which resolved the issue.The patient was hospitalized for a few days and there was no permanent damage to the patient.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 60/6 GREY
• MDR Report Key: 8542896
• Report Number: 3003442380-2019-01306
• Device Sequence Number: 10855994
• Product Code: FPA
• UDI-Device Identifier: 05705244006874
• UDI-Public: 05705244006874
• 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: 05/17/2017
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1