MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 110/9 PCC MCAN

Model Number	MMT-396600
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Event occurred in (b)(6).It was reported that the patient experienced hyperglycemia on friday because she had a kinked cannula and she also experienced high blood glucose levels on saturday due to a second infusion which was kinked as well.Further, she stated that the most recent incident took her to the hospital was the one on sunday, (b)(6) 2020 at 8:30 am.At the time of the incident, the patient's blood glucose level was 23.0 mmol/l and she had a back -up plan with pens and needles.Subsequently, on (b)(6) 2020, she was taken to the emergency room and was admitted in critical care unit, as her blood glucose level was 8.0 mmol/l, and this was after they changed the infusion set which had a kinked cannula.It was also reported that the infusion was changed in the morning on the same day.Reportedly, she had large amount of ketones (diabetic ketoacidosis) which was due to a bent cannula and she was so confused that she did not take a shot.After three days of hospitalization, on (b)(6) 2020 at 4:00 pm, she was discharged from the hospital.Currently, her blood glucose level was 10.4 mmol/l.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/9 PCC MCAN
• MDR Report Key: 10969266
• Report Number: 3003442380-2020-00466
• Device Sequence Number: 2470081
• Product Code: FPA
• UDI-Device Identifier: 05705244006751
• UDI-Public: 05705244006751
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/01/2022
• Device Model Number: MMT-396600
• Device Lot Number: 5276354
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1