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 united states.The physician's assistant reported that the infusion set's cannula was bent.It was noticed when the patient removed the site which she used during high blood glucose levels.Reportedly, her blood glucose was over 600 mg/dl prior going to the hospital and she experienced diabetic ketoacidosis.She self-treated with multiple daily injections and changed the site twice.Subsequently, she was admitted in the hospital, where the health care professional assessed the ketone level as dangerous and life threatening.She received insulin drip, subcutaneous insulin, lantus (insulin glargine) and lipozene as corrective treatment.She was currently on injections and drip, but the issue was not fully resolved.She was hospitalized for three days and there was no permanent damage to the patient.Moreover, she had started to use pens since then.The patient's blood glucose was reported to be 321 mg/dl after one day of hospitalisation.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: 8538575
• Report Number: 3003442380-2019-01345
• Device Sequence Number: 2431747
• 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: 03/15/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1