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

Model Number	MMT-398
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.On (b)(6) 2020, it was reported that the infusion set's tubing came out at the quick release and the patient woke up with blood glucose level of 540 mg/dl.The patient stated that this issue occurred maybe five times in 20 years.Upon investigation performed on the returned used device (1 used set), it was found that the tubing detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MECA
• MDR Report Key: 11053746
• Report Number: 3003442380-2020-00482
• Device Sequence Number: 19576928
• 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

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: 02/01/2022
• Device Model Number: MMT-398
• Device Lot Number: 5260526
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1