MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 60/6 PCC MCAN

Model Number	MMT-399600
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 (b)(6).On (b)(6) 2021, the patient reported of headache due to high blood glucose level which was after the infusion set's tubing had detached as it was not connected correctly.The patient tried to treat the high blood glucose level with manual injections (four units).At the time of the incident the patient's blood glucose level was 24.2 mmol/l.The infusion set had been changed three days ago.Currently, the patient's blood glucose level was 20.3 mmol/l.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/6 PCC MCAN
• MDR Report Key: 11662627
• Report Number: 3003442380-2021-00213
• Device Sequence Number: 2980535
• Product Code: FPA
• UDI-Device Identifier: 05705244006317
• UDI-Public: 05705244006317
• 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-399600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1