MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 PCC MCAN

Model Number	MMT-397600
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 (b)(6).On (b)(6) 2022, the patient's mother reported that the plastic piece dislodged from the tape and the whole of the cannula detached.On (b)(6) 2022, the patient's blood glucose level was reported as 18.3 mmol/l.The site location was right side of patient's abdomen, and the pump was located on the waist band.Moreover, the infusion had been used for a day before.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the mother was in process of changing the infusion set as the patient had high blood glucose levels.No further information available.

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/9 PCC MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13305872
• Report Number: 3003442380-2022-00176
• Device Sequence Number: 3424600
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• 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
• Report Date (Section B): 01/20/2022

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
• Device Expiration Date: 08/01/2022
• Device Model Number: MMT-397600
• Device Lot Number: 5279089
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/20/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown