MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 80/9 PCC

Model Number	MMT-386
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, it was reported by the patient that the infusion set's leaked at the quick release, although the quick release was tightly connected.It was noticed when there was a smell of insulin and it happened with four infusion sets.The infusion set had been used for 2-3 days and there was no stress or pull on the infusion set tubing.Upon investigation of the returned used device (1 tubing), it showed that the tubing was detached from the tubing-tubing connector.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 80/9 PCC
• MDR Report Key: 10688624
• Report Number: 3003442380-2020-00424
• Device Sequence Number: 11556951
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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 Model Number: MMT-386
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1