MAUDE Adverse Event Report: QUICK-SET®; QUICK-SET 60/6

Lot Number	5122421
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.It was reported that the tubing on insulin delivery infusion set detached from the set where insulin was infused into the body.Reportedly, this caused a failure of insulin to be infused into the patient's body which resulted in an elevated blood glucose level.Fortunately, the patient's continuous glucose monitor alerted to it and allowed the patient to evaluate it and correct it with an injection.Moreover, a new set tubing was installed, and blood glucose control was successfully implemented.No further information available.

• Brand Name: QUICK-SET®
• Common Device Name: QUICK-SET 60/6
• MDR Report Key: 8494837
• Report Number: 3003442380-2019-00992
• Device Sequence Number: 1780853
• Product Code: FPA
• UDI-Device Identifier: 05705244006270
• UDI-Public: 05705244006270
• 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 Expiration Date: 11/01/2018
• Device Lot Number: 5122421
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1