MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 110/9 PCC

Lot Number	5211892
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 (b)(6).The patient reported that while sleeping the infusion set tubing detached at quick release.The patient woke up and had high blood glucose level (16 mmol/l) due to tubing detachment therefore she changed her infusion set.The site was at the right leg.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 110/9 PCC
• MDR Report Key: 8264746
• Report Number: 3003442380-2019-00272
• Device Sequence Number: 19221126
• Product Code: FPA
• UDI-Device Identifier: 05705244006751
• UDI-Public: 05705244006751
• 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: 11/01/2020
• Device Lot Number: 5211892
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/21/2019
• Patient Sequence Number: 1