MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC

Model Number	MMT-386
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
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that while the patient was busy doing a lot of things and had a banquet to go to, she felt sick as her blood glucose level raised, therefore her daughter took her to the emergency room.Subsequently on (b)(6) 2019, they transported her to the hospital by an ambulance and at 09:00 pm, she was hospitalized due to high blood glucose level of 1006 mg/dl.While in the hospital, they checked her site and it was bent due to which she experienced high blood glucose level.Reportedly, the patient had a liver transplant and she was on an anti-rejection medication that does affect her memory when something was told but may not remember what to do.During hospitalization, she received insulin via intravenous route as corrective treatment.On (b)(6) 2019, she was released from the hospital.On the day of this report ((b)(6) 2020), she only had coffee and her blood glucose level was 364 mg/dl.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: QUICK-SET 80/9 PCC
• MDR Report Key: 9669200
• Report Number: 3003442380-2020-00144
• Device Sequence Number: 11491393
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Model Number: MMT-386
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1