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

Lot Number 5208797

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 had an issue with the infusion set and went to the emergency room.The patient stayed in the house, till the blood glucose level was 332 mg/dl.Patient's blood glucose level was 453 mg/dl when admitted to the hospital.The patient was hospitalized for diabetes ketoacidosis, nausea, had dry mouth and was feeling bad.The patient was hospitalized for two nights.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: 8553635
• MDR Text Key: 143218266
• Report Number: 3003442380-2019-01323
• 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: 04/26/2019
• 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: 5208797
• Date Manufacturer Received: 02/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1