MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 110/6 GREY TCAP

Lot Number	5247393
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.It was reported that the patient faced bent cannula issue with three infusion sets that caused high reading of the ketones as the test was performed at home and elevated blood glucose level reported to be 460 mg/dl at the time of this event.The patient changed out infusion set and after third infusion set change, he decided to go to the hospital.The patient was hospitalized with borderline diabetic ketoacidosis.The hospital monitored his blood glucose level and ran ketones test.Ketones were extra-large by the time he reached the hospital.He was given intravenous fluids and his father continued to deliver insulin through pump but switched infusion sets, which resolved the issue.The infusion set had been in use for less than a day.The patient did not notice any damage when the package was first opened.There was no permanent damage to the patient.The patient stayed in the hospital for two 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: AUTOSOFT 90
• Common Device Name: INSET II 110/6 GREY TCAP
• MDR Report Key: 8657116
• Report Number: 3003442380-2019-01507
• Device Sequence Number: 2286716
• Product Code: FPA
• UDI-Device Identifier: 05705244014336
• UDI-Public: 05705244014336
• 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: 07/01/2021
• Device Lot Number: 5247393
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1