MAUDE Adverse Event Report: INSET¿30; INSET 30 60/13 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 having faced bent cannula issue that caused high blood glucose level, which was self-treated with bolus from the pump and manual injection.Thereafter, the patient went to the emergency room and upon admission, patient's blood glucose level was approximately 400 mg/dl.The patient also had large ketones and the level of ketones was not identified as dangerous/life threatening by the healthcare professional.The patient received fluids via intravenous route and insulin drip as corrective treatment.The patient stayed in the emergency room for a few hours.The patient still experienced elevated blood glucose level that required attention and showed signs of diabetic ketoacidosis due to which, subsequently, the patient was hospitalized.The patient received fluids via intravenous route and insulin drip, which resolved the issue.The infusion set had been in use for approximately one day.There was no permanent damage to the patient and the patient stayed in the hospital for five days.The patient performed a supply change and resumed insulin from the pump after being released from the hospital.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¿30
• Common Device Name: INSET 30 60/13 GREY
• MDR Report Key: 8539211
• Report Number: 3003442380-2019-01365
• Device Sequence Number: 361169
• Product Code: FPA
• UDI-Device Identifier: 05705244007123
• UDI-Public: 05705244007123
• Combination Product (Y/N): N
• PMA/510(K) Number: K061374
• 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: 01/11/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1