MAUDE Adverse Event Report: QUICK-SET®; QUICK-SET 110/6

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 when she woke up in the morning, she had high blood glucose level (27 mmol/l) as she did not know whether she had insulin at night or not.Reportedly, the tubing came apart from where it was attached to her site.The patient treated high blood glucose level with her pump and it was still coming down.No further information available.

• Brand Name: QUICK-SET®
• Common Device Name: QUICK-SET 110/6
• MDR Report Key: 8263039
• Report Number: 3003442380-2019-00217
• Device Sequence Number: 1672722
• Product Code: FPA
• UDI-Device Identifier: 05705244006638
• UDI-Public: 05705244006638
• Combination Product (Y/N): N
• PMA/510(K) Number: K991759
• 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: 10/23/2017
• Initial Report FDA Received Date: 01/19/2019
• Patient Sequence Number: 1