MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 SC1 MECA

Model Number MMT-397A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set's tubing detached at the quick release, as it got detached from the adhesive of the site while doing normal activity.Her blood glucose level was over 500 mg/dl.This issue occurred with four infusion sets and it happened for three days till the patient was sent to the hospital on (b)(6) 2022 with blood glucose level of 600 mg/dl.The site location was the patient's abdomen, and the pump was on the same side.The infusion set had been used for less than one day.Further, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Moreover, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.She was admitted in the hospital for two days.Currently, the patient's blood glucose level was 242 mg/dl.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15162062
• MDR Text Key: 304838555
• Report Number: 3003442380-2022-00918
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017573
• UDI-Public: 05705244017573
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

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?: Yes
• Device Expiration Date: 04/01/2024
• Device Model Number: MMT-397A
• Device Lot Number: 5352707
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/04/2022
• Patient Sequence Number: 1