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

Lot Number	5217945
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 (b)(6).The patient had a bent cannula due to which she changed her infusion set.Subsequently, she became unwell with high blood glucose level reported to be 28.8 mmol/l at the time and ketones at more than 6 mmol/l.She was then admitted to the hospital due to high blood glucose level and diabetic ketoacidosis while she was still connected to the pump.She was treated with a sliding scale and saline drip.The pump remained connected but suspended whilst customer was in the hospital.The patient ended up removing the cannula on approximately the second day of being in hospital and found that the cannula was clearly bent.The night before being discharged, the patient was started back on the pump with a whole new set/reservoir and insulin.The patient reported that when she used the older blue serter, she seemed to get bent cannulas and if she used the new grey/green serter then the set inserted fine.It was found that she had scarred, hardened lumps and was overweight.The patient was release from the hospital after three days.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: 8543378
• Report Number: 3003442380-2019-01154
• Device Sequence Number: 312245
• 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: 12/01/2020
• Device Lot Number: 5217945
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1