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	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).It was reported that the patient experienced high blood glucose level due to infusion set's tubing detachment as the patient notice a smell of insulin.Moreover, the catheter was in place from past two days.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MECA
• MDR Report Key: 11548542
• Report Number: 3003442380-2021-00184
• Device Sequence Number: 17155574
• 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: 04/01/2023
• Device Model Number: MMT-398
• Device Lot Number: 5319035
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1