MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 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
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that she inserted the infusion set at night and the next day, she noticed that it had detached close to the site location while she was sleeping.Her blood glucose level was 25 mmol/l and she corrected it manually.The site location might have been her arm and the pump was clipped onto her collar on the left side of her neck.Reportedly, the infusions were stored at room temperature.There was no stress or pull on the tubing and 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 80/9 PCC
• MDR Report Key: 8661818
• Report Number: 3003442380-2019-01515
• Device Sequence Number: 16689966
• Product Code: FPA
• UDI-Device Identifier: 05705244006553
• UDI-Public: 05705244006553
• 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: 10/22/2018
• Initial Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1