MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 60/13 GREY TCAP

Lot Number	5207867
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
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 stated that the infusion set might not have delivered insulin properly due to which she experienced diabetic ketoacidosis and was hospitalized.At the time of this event, her blood glucose level was at 300 mg/dl.The issue did not resolve even after infusion set change.Her health care professional placed her on multiple daily injection therapy in addition to her pump therapy.There was no damage noticed when the package was first opened.The patient was hospitalized for 2 days.No further information available.

• Brand Name: AUTOSOFT 30
• Common Device Name: INSET 30 60/13 GREY TCAP
• MDR Report Key: 8314170
• Report Number: 3003442380-2019-00454
• Device Sequence Number: 62579
• Product Code: FPA
• UDI-Device Identifier: 05705244014602
• UDI-Public: 05705244014602
• Combination Product (Y/N): N
• PMA/510(K) Number: K061374
• 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: 11/01/2020
• Device Lot Number: 5207867
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1