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

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient stated, tubing was disconnected from the housing that connects to the body.The infusion set the patient used got detached from the quick release (qr) in the middle of night while he was sleeping.Reportedly, the patient was using the infusion set for 5 days as a lot of insulin was left in the reservoir.The location of the detachment was where the tubing connects to the qr.There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body.No further information available.

• Brand Name: QUICK-SET®
• Type of Device: QUICK-SET 60/6
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8202155
• MDR Text Key: 131587206
• Report Number: 3003442380-2018-00140
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006270
• UDI-Public: 05705244006270
• Combination Product (y/n): N
• PMA/PMN Number: K991759
• 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: 11/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1