MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 60/9 PCC

Model Number MMT-397

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that while the patient was sleeping, the infusion set's tubing had detached at the site.The site location was at the left lower side of the abdomen and the pump was located on left side of the waist.Further, the infusion set had been used for two days.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, the there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Furthermore, it was stated that the patient had very high blood glucose levels.No further information available.

Event Description

On 27-oct-2020: follow up information was submitted because result of complaint investigation of the returned used device (1 tubing) showed that all test results were within specifications.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that while the patient was sleeping, the infusion set's tubing had detached at the site.The site location was at the left lower side of the abdomen and the pump was located on left side of the waist.Further, the infusion set had been used for two days.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, the there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Furthermore, it was stated that the patient had very high blood glucose levels.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK-SET 60/9 PCC
• MDR Report Key: 10578414
• MDR Text Key: 208329725
• Report Number: 3003442380-2020-00391
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2023
• Device Model Number: MMT-397
• Device Lot Number: 5317519
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/27/2020
• Patient Sequence Number: 1