MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.It was reported that in the morning of this report when the patient woke up, the tubing was disconnected from the quick release while sleeping and could see the glue.Patient's blood glucose level was 250 mg/dl and treated it with manual injection with a syringe.The site location was at the thigh and the pump was connected to the pants.The infusion had been in use for two days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.In the investigation it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 80/6 PCC
• MDR Report Key: 8560560
• Report Number: 3003442380-2019-01422
• Device Sequence Number: 11159667
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1