MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 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 (b)(6).The tube of the patient's infusion set disconnected at quick release ring.She experienced this issue several times (6 times) at night while she was sleeping.Her blood glucose level more than 400 mg/dl in the morning.She had nausea, vomiting and her ketone levels were high.The set was inserted on the belly and the pump was not attached to the body, it was loose on the bed.The patient self-treated her high blood glucose level (inserting novorapid).The location of detachment was at quick release and the site of insertion was on the belly.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 80/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8202247
• MDR Text Key: 131587156
• Report Number: 3003442380-2018-00171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/28/2018
• Type of Device Usage: N
• Patient Sequence Number: 1