MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 110/13 GREY TCAP

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.It was reported that the patient visited the emergency room as she experienced high blood glucose level reported to be 546 mg/dl at the time of arrival.The patient received insulin injections, fluids via intravenous route and spent 12 hours in the emergency room.The patient's blood glucose level was at 441 mg/dl and was still not feeling well when she was admitted to the intensive care unit for diabetic ketoacidosis.She had ketone levels which the health care professional assessed as dangerous/life threatening.The cannula was kinked when inspected upon removal and the patient also had cold which she believed to have contributed to high blood glucose level.She received fluids via intravenous route and insulin as corrective treatment, which resolved the issue.The infusion set had been in use for approximately 24 hours and there was no permanent damage to the patient.She was hospitalized 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 30
• Common Device Name: INSET 30 110/13 GREY TCAP
• MDR Report Key: 8682156
• Report Number: 3003442380-2019-01534
• Device Sequence Number: 2309198
• Product Code: FPA
• UDI-Device Identifier: 05705244014633
• UDI-Public: 05705244014633
• 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: 05/21/2019
• Initial Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1