MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/9 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 (b)(6).The patient reported that she had high blood glucose level when she changed her set.Her blood glucose level started going down and she went to sleep.She woke up with blood glucose level at 19 mmol/l.The patient took a bolus again and went to work the next day but her blood glucose level never came down.Therefore, she decided to check herself in the emergency room as she started having chest pain.The patient experienced high blood glucose level reported to be 25 mmol/l at the time of incident and also felt slightly nauseous.Subsequently, the patient was taken to the intensive care unit due to diabetic ketoacidosis and blood glucose level upon admission was 18.4 mmol/l.Upon removal of the infusion set, the cannula was found to be completely bent.The patient had stretch marks on her abdomen.The patient had been in the hospital for two days and was still there with blood glucose level at 6.8 mmol/l, at the time of this report.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 60/9 PCC
• MDR Report Key: 8538543
• Report Number: 3003442380-2019-01376
• Device Sequence Number: 361085
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• 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: 06/26/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1