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

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

(b)(4).Event occurred in the united states.The patient's nurse stated that some tubing did not work, and she had a lot trouble while connecting.The patient experienced high blood glucose and fell.The patient was hospitalized 5 days prior to this report possibly due to generalized weakness, suspected diabetic ketoacidosis and high blood glucose level, which was reported to be around 500 mg/dl.At the time of this report, the patient was still in hospital.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: 8360757
• MDR Text Key: 136845854
• Report Number: 3003442380-2019-00261
• 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: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/26/2017
• Type of Device Usage: N
• Patient Sequence Number: 1