MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/9 GREY

Lot Number	5177976
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 experienced high blood glucose level reported to be 500 mg/dl, at the time of incident and the patient tried to self-treat it with a bolus using the pump.She was unaware that her blood glucose level had elevated until paramedics arrived at her home.They removed the infusion set and saw that the cannula was bent due to which the patient was not receiving insulin.She experienced high blood glucose level, low blood pressure and urinary track infection due to which she was admitted to the hospital.The patient also had ketones and its level was identified to be dangerous/life threatening by a healthcare professional.She received intravenous drip in the hospital, which resolved the issue.The infusion set had been in use for one day.The patient faced bent cannula issue with three infusion sets.The patient had not noticed any damage when the package was first opened.There was no permanent damage to the patient and she stayed in the hospital for six 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: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/9 GREY
• MDR Report Key: 8543115
• Report Number: 3003442380-2019-01409
• Device Sequence Number: 16576969
• Product Code: FPA
• UDI-Device Identifier: 05705244004450
• UDI-Public: 05705244004450
• 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 Expiration Date: 01/01/2020
• Device Lot Number: 5177976
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1