MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 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.The patient reported a kinked cannula infusion set.Reportedly, her blood glucose was above 600 mg/dl and she tried to give a bolus.Subsequently, she went to the emergency room, as her blood glucose had risen substantially after she ate a large breakfast.Upon arrival in the emergency room, her blood glucose level was approximately 500 mg/dl, had ketones and she stayed there for six hours.The health care professional assessed her ketone level as dangerous/life threatening and she received unspecified medication via intravenous route.She was admitted to the hospital, with blood glucose level of approximately 600 mg/dl, where she received intravenous insulin drops as corrective treatment, and she had some blood investigations done which resolved the issue and there was no permanent damage to the patient.She was released from the hospital after three 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 60/6 GREY TCAP
• MDR Report Key: 8576519
• Report Number: 3003442380-2019-01440
• Device Sequence Number: 1809532
• 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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1