MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC

Lot Number	UNKNOWN
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 abdominal pain, difficulty in breathing and got cracked ribs because of breathing issues.Further, his blood glucose level was over 600 mg/dl, which he tried to treat with a bolus.In the morning of (b)(6) 2019, the blood glucose levels were reported to be 570 mg/dl, 410 mg/dl and 161 mg/dl (at 11:32 am).The infusion set was changed on (b)(6) 2019, site location was right side.Reportedly, on (b)(6) 2019 (friday), he was not getting insulin, so his wife brought him to the emergency room.His blood glucose level was over 600 mg/dl, then it went down to 400 mg/dl, when he got to the hospital.Upon removal of the infusion set, it was found to be bent.During hospitalization, he received insulin injections as corrective treatment.Currently, his blood glucose level was reported to be 327 mg/dl and he was still in the hospital as per report dated 28-oct-2019.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 80/6 PCC
• MDR Report Key: 9345926
• Report Number: 3003442380-2019-01929
• Device Sequence Number: 13981840
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1