MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 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 patient reported that the infusion set's tubing detached itself, while sleeping.Moreover, the patient had positive results in ketones test, nausea, vomiting and the blood glucose level was 23 mmol/l at the time of this event.Further, on (b)(6) 2019, the patient changed the infusion set.Reportedly, the last night from the day of this report ((b)(6) 2019), patient's blood glucose level was high.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 80/9 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9514805
• MDR Text Key: 183277592
• Report Number: 3003442380-2019-01993
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• 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: 11/27/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1