MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Lot Number	5221829
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
Unomedical reference number (b)(4).Event occurred in the united states.In the morning of (b)(6) 2019, the patient reported that her blood glucose level was over 300 mg/dl and while the patient was sleeping, her infusion set's tubing came apart close to the site location.The site location was at patient's right buttock and the pump was in right pocket of her shirt.The infusion had been in use for three 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 patient's body.Upon investigation performed on the returned used device (1 set), 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 46/6 PCC
• MDR Report Key: 8948924
• Report Number: 3003442380-2019-01772
• Device Sequence Number: 2129417
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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 Expiration Date: 05/01/2021
• Device Lot Number: 5221829
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Patient Sequence Number: 1