MAUDE Adverse Event Report: SURE-T® PARADIGM®; UNO CONTACT DETACH G29 60/6 SC1 MIMX

Model Number MMT-864A

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient experienced high blood glucose level on (b)(6) 2021, so she took more insulin and changed everything (tubing, infusion set, reservoir and insulin), she took a bolus for dinner and went to bed with blood glucose still high.Moreover, she woke up vomiting every two hours, and she was unable to bring her blood glucose level below 20 mmol/l, so she was taken to the hospital by son and husband.Reportedly, on (b)(6) 2021, she was admitted to the emergency room, as she was dehydrated and had nausea.Moreover, her blood glucose level was above 20 mmol/l, she experienced diabetic ketoacidosis and had ketones (diabetic ketoacidosis strip was the highest color it could get).Further, when she removed the needle it was found that the cannula was bent.The infusion had been used for less than 12 hours.During hospitalization, she was administered insulin manually, medication for nausea and unspecified medication intravenously.Further, she stayed overnight at the hospital and was released from the hospital on (b)(6) 2021 at 5:00 pm.Moreover, as reported on (b)(6)2021, the same event occurred last night, her blood glucose level went up to 32 mmol/l and when she removed the needle it was 45 degree bent.The site location was her buttocks.Currently, her blood glucose level was 13.2 mmol/l.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: SURE-T® PARADIGM®
• Type of Device: UNO CONTACT DETACH G29 60/6 SC1 MIMX
• MDR Report Key: 12473242
• MDR Text Key: 271444665
• Report Number: 3003442380-2021-00465
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019317
• UDI-Public: 05705244019317
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2023
• Device Model Number: MMT-864A
• Device Lot Number: 5341064
• Date Manufacturer Received: 09/01/2021
• Type of Device Usage: N
• Patient Sequence Number: 1