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

Lot Number 5191498

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 reported that she was not receiving insulin which led to high blood glucose level and diabetic ketoacidosis.Her blood glucose was 806 mg/dl when she was admitted into the hospital.Her blood glucose levels were elevated and after she was unable to bring her blood glucose level down via blousing with pump as well as delivering injections she drove herself to the hospital.She received insulin drip and various fluids to help potassium levels as corrective treatment which resolved the issue.She did not notice any damage when the package was first opened.The infusion had been in use for less than three days.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: INSET II 60/6 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8468860
• MDR Text Key: 140433491
• Report Number: 3003442380-2019-00892
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014305
• UDI-Public: 05705244014305
• Combination Product (y/n): N
• PMA/PMN Number: K032854
• 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: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 5191498
• Date Manufacturer Received: 03/07/2018
• Type of Device Usage: N
• Patient Sequence Number: 1