MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 GREY TCAP

Lot Number	5191481
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 faced kinked cannula issue due to which the patient experienced high blood glucose level, which was self-treated with a bolus using the pump.The patient went to the emergency room and upon arrival, blood glucose level was 426 mg/dl.Patient's level of ketones was identified as dangerous/life threatening by a health care professional.In the emergency room, triage was done, the pump was removed, patient was put on an insulin drip and they drew the patient's blood.When the patient left the emergency room, blood glucose level was 219 mg/dl and the patient experienced nausea and vomiting.The patient stayed in the emergency room for approximately five hours and was then hospitalized.The patient received insulin, fluids and patient's basic metabolic panel was monitored.The infusion set had been in use for one day.The patient stayed in the hospital for two days.At the time of this report, issue had resolved, and patient was doing well at home.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 60/6 GREY TCAP
• MDR Report Key: 8543388
• Report Number: 3003442380-2019-01155
• Device Sequence Number: 16243290
• Product Code: FPA
• UDI-Device Identifier: 05705244014305
• UDI-Public: 05705244014305
• 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: 5191481
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1