MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 110/6 PCC MECA

Model Number	MMT-398
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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) 2021, it was reported that the patient's infusion set, and tube part was broken, and insulin leaked.Reportedly, the patient was hospitalized at the hospital when this event occurred.The patient replaced the infusion set on (b)(6) 2021.During that time, she had used it without problems, and she did not remember getting it caught or dropped.There was no zipper on the pouch to put the pump in, and it was not pinched.No further information available.
Event or Problem Description
On 12-may-2021: follow up information was submitted because the result of complaint investigation of the returned used device (1 set) showed that all the test results were within specification.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that the patient's infusion set, and tube part was broken, and insulin leaked.Reportedly, the patient was hospitalized at the hospital when this event occurred.The patient replaced the infusion set on (b)(6) 2021.During that time, she had used it without problems, and she did not remember getting it caught or dropped.There was no zipper on the pouch to put the pump in, and it was not pinched.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MECA
• MDR Report Key: 11639708
• Report Number: 3003442380-2021-00201
• Device Sequence Number: 2998825
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• 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,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: 10/01/2023
• Device Model Number: MMT-398
• Device Lot Number: 5338736
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/12/2021
• Patient Sequence Number: 1