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

Lot Number	5262071
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 faced bent cannula issue on (b)(6) 2019 due to which she changed the infusion set and the cartridge.She gave herself a manual injection with an insulin pen.She was not sure if insulin pen was expired but knew that there was not enough insulin in pen to lower her blood glucose level.Thereafter, the second cannula was also found to be bent.The patient was tested for ketones in the night of (b)(6) 2019 and her level was not identified to be dangerous/life threatening by a healthcare professional.The patient experienced high blood glucose level due to two bent cannulas and since she was not receiving insulin from (b)(6) 2019 morning (over 12 hours).Subsequently, she went to the emergency room with blood glucose level over 500 mg/dl and stayed there for 30 minutes.When she left the emergency room, her blood glucose level was high reported to be over 600 mg/dl and she was delirious.Then, she was admitted to the intensive care unit on (b)(6) 2019, where she received fluids through intravenous route and manual injections, which resolved the issue.The infusion set had been in use for less than a day and there was no permanent damage to the patient.She did not notice any damage when the package was first opened.She was released from the hospital on (b)(6) 2019.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 was available.

• Brand Name: AUTOSOFT 90
• Common Device Name: INSET II 60/6 GREY TCAP
• MDR Report Key: 8743284
• Report Number: 3003442380-2019-01581
• Device Sequence Number: 13788580
• 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 Expiration Date: 11/01/2021
• Device Lot Number: 5262071
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1