MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Lot Number	5201289
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.The patient reported that her set kept coming off as the site was disconnected from her (cannula) at the quick release while sleeping, this issue occurred numerous times and thought it was her fault.In the morning of this report, this issue occurred again, and her blood glucose level was 396 mg/dl.This issue occurred with the same lot (5 boxes) a dozen times.The site location was at the thigh because the abdomen does not work well for her (harden tissue) and the pump was on her waist inside a fanny pack.The infusion was in use for half a day.Reportedly, the infusions were stored in her boxes in her hallway.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.
Event or Problem Description
Initially, the case was submitted on 22-mar-2019.However, upon receipt of follow up information of complaint investigation, all the test results were within specifications, therefore the infusion set cannot be related to the reported event.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that her set kept coming off as the site was disconnected from her (cannula) at the quick release while sleeping, this issue occurred numerous times and thought it was her fault.In the morning of this report, this issue occurred again, and her blood glucose level was 396 mg/dl.This issue occurred with the same lot (5 boxes) a dozen times.The site location was at the thigh because the abdomen does not work well for her (harden tissue) and the pump was on her waist inside a fanny pack.The infusion was in use for half a day.Reportedly, the infusions were stored in her boxes in her hallway.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 46/6 PCC
• MDR Report Key: 8443202
• Report Number: 3003442380-2019-00646
• Device Sequence Number: 2839464
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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,Followup

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: 09/01/2020
• Device Lot Number: 5201289
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 09/27/2019
• Patient Sequence Number: 1