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

Lot Number	5175940
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 (b)(6).The patient reported that due to unstable blood glucose level he woke up at night and noticed the set was completely disconnected at quick release and had issues with 2 other sets where he found moisture around the tape at the site which happened in a span of 18 days.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 110/9 PCC
• MDR Report Key: 8263036
• Report Number: 3003442380-2019-00220
• Device Sequence Number: 1911875
• 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: 05/01/2020
• Device Lot Number: 5175940
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 01/19/2019
• Patient Sequence Number: 1