MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Model Number	MMT-394
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.The patient reported that he faced a bent cannula issue and the infusion set being stuck inside of the serter walls, so insulin did not flow.Reportedly, the inside walls caused infusion set to stick to it.It was also stated by the patient that the serter did not show signs of physical/cosmetic damage.Moreover, he cleaned the serter after every 3-4 uses.Further, while he inserted the infusion set (needle- blue plunger) in, it stuck inside the serter, but he and his wife thought it was in there.Subsequently, on (b)(6) 2020 at 3:00 pm, he was admitted in the hospital as his blood glucose level was over 1200 mg/dl and he experienced diabetic ketoacidosis.Moreover, the infusion set was last changed on (b)(6) 2020 at the nighttime.During hospitalization, he received a drip intravenously, as he had a intravenous port on his chest that's how they gave the insulin.On 15-mar-2020 at 5:00 pm, he was released from the hospital.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 46/6 PCC
• MDR Report Key: 9902384
• Report Number: 3003442380-2020-00229
• Device Sequence Number: 2717922
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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-394
• Device Lot Number: 5927684
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/31/2020
• Patient Sequence Number: 1