MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states the patient had faulty infusion set as it was blocked and the tubing had removed from piece that goes on set.The patient's blood glucose level at the time of issue was over 400 mg/dl and had ketones level as well.Currently, her blood glucose level was 350 mg/dl.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 60/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8202218
• MDR Text Key: 131587021
• Report Number: 3003442380-2018-00173
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006331
• UDI-Public: 05705244006331
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• 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: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1