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

Lot Number 5207867

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event 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
• Type of Device: INSET 30 60/13 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8314170
• MDR Text Key: 135342892
• Report Number: 3003442380-2019-00454
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014602
• UDI-Public: 05705244014602
• Combination Product (y/n): N
• PMA/PMN Number: K061374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2020
• Device Lot Number: 5207867
• Date Manufacturer Received: 12/19/2018
• Type of Device Usage: N
• Patient Sequence Number: 1