MAUDE Adverse Event Report: QUICK-SET®; QUICK-SET 60/9

Lot Number	5153038
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that while sleeping, the tubing snapped off and was no longer attached.Her blood glucose level was 467 mg/dl, which she treated with a shot.She changed the tubing and everything was fine.She also had issues from time to time with getting the quick release back on after taking a shower.No further information available.

• Brand Name: QUICK-SET®
• Common Device Name: QUICK-SET 60/9
• MDR Report Key: 8467977
• Report Number: 3003442380-2019-00857
• Device Sequence Number: 1515645
• Product Code: FPA
• UDI-Device Identifier: 05705244006294
• UDI-Public: 05705244006294
• 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: 06/15/2019
• Device Lot Number: 5153038
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1