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.It was reported that the patient experienced high blood glucose level due to issues with the tubing and been trying to bolus.Therefore, the patient tried to treat it with syringe, but the patient was admitted to the hospital two times.The first-time, patient was hospitalized on (b)(6) 2020, with blood glucose level of 540 mg/dl and on (b)(6) 2020, the patient was hospitalized for the second time with blood glucose level of 605 mg/dl due to diabetic ketoacidosis.During hospitalization, the patient received insulin intravenously as corrective treatment.For first hospitalization, the patient stayed overnight in the hospital and next day, on (b)(6) 2020, the patient was released and for second hospitalization, the patient was released on (b)(6) 2020.Moreover, the patient faced insulin flow block with four sets, but did not get insulin flow block on the set that he used recently.Later, it was found that the cannula was bent.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: 10383875
• Report Number: 3003442380-2020-00350
• Device Sequence Number: 16645294
• 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 Expiration Date: 12/01/2021
• Device Model Number: MMT-394
• Device Lot Number: 5221890
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/10/2020
• Patient Sequence Number: 1