MAUDE Adverse Event Report: INFUSION DEVICES - UNKOWN

Lot Number UNKNOWN

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 faced issues with infusion set's tubing as it did not deliver insulin.The patient felt sick as her blood glucose was raised and she treated it with multiple daily injections.She went to the emergency room and stayed there for few hours and was subsequently hospitalized in the step-down intensive care unit.Upon arrival in emergency, her blood glucose was 595 mg/dl and she experienced diabetic ketoacidosis.The patient was admitted to hospital and the health care professional assessed the ketone level as dangerous/life threatening.The patient received insulin drip, intravenous bag fluids with potassium as corrective treatment which resolved the issue.The patient was hospitalized for 2 days.Reportedly, she was unsure about any incomplete bolus alerts.No further information available.

• Brand Name: INFUSION DEVICES - UNKOWN
• Type of Device: INFUSION DEVICES - UNKOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8450939
• MDR Text Key: 139798462
• Report Number: 3003442380-2019-00695
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1