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 experienced high blood glucose level due to bent needle and was not delivering insulin.Therefore, she tried to treat it with a bolus via pump, but on (b)(6) 2020, the patient was admitted to the hospital due to high blood glucose level.Patient's highest blood glucose level was 750 mg/dl.Moreover, the infusion set had been used for 2-3 days.During hospitalization, she received fluids of saline, insulin and intravenous medication (drug name unknown) as corrective treatment, which resolved the issue.On (b)(6) 2020, the patient was released from the hospital with no permanent damage.Reportedly, a day before this report, she again faced a bent needle issue and her blood glucose level was 750 mg/dl at the time of this event.She did not notice any damage when the package was first opened.Further, they replaced the infusion set and insulin was resumed successfully.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: 10776652
• Report Number: 3003442380-2020-00441
• Device Sequence Number: 13709270
• 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 Expiration Date: 04/01/2023
• Device Model Number: 1000275
• Device Lot Number: 5308770
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1