MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/9 GREY TCAP

Model Number	1000275
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 had three bent/kinked cannulas.At the time of the event, the patient's blood glucose level was more than 500 mg/dl.It was stated that the patient had insulin pooling at the site and the insulin was not being distributed to his body which caused high blood glucose levels because of kinked/clogged cannula.Moreover, when the cannula was removed it was found that the cannula was bent at the very tip of the cannula, when pressed on.Further, he changed his infusion, replaced the site and did a correction bolus via pump in order to address the issue but his blood glucose levels still went up.On an unknown date in (b)(6) 2020, he was admitted to the hospital as he had moderate ketones and high blood glucose levels.He was administered some unspecified medication intravenously (drug name unknown), fluids of saline and insulin which resolved the issue.After three days of stay in the hospital, he was released from the hospital with no permanent damage.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 60/9 GREY TCAP
• MDR Report Key: 10598314
• Report Number: 3003442380-2020-00402
• Device Sequence Number: 14308923
• Product Code: FPA
• UDI-Device Identifier: 05705244014367
• UDI-Public: 05705244014367
• Combination Product (Y/N): Y
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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 Model Number: 1000275
• Device Lot Number: 5272342
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1