MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 80/9 PCC MECA

Model Number MMT-386

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, it was reported that, the infusion set's cord/tubing was broken 7 inches from where it connects closer to the site, while she was sitting in the couch.She put it this morning and when she looked down, it was observed that both the pieces landed on the couch.The site location was patient's left abdomen and the pump was in her left pocket.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, patient's blood glucose level was 130 mg/dl.No further information available.

Event Description

On 22-apr-2021: follow up information was submitted to update awareness date and result of complaint investigation of the returned used device (1 tubing) showed that the tubing was returned damage (cut).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.On (b)(6) 2021, it was reported that, the infusion set's cord/tubing was broken 7 inches from where it connects closer to the site, while she was sitting in the couch.She put it this morning and when she looked down, it was observed that both the pieces landed on the couch.The site location was patient's left abdomen and the pump was in her left pocket.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, patient's blood glucose level was 130 mg/dl.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: UNO QUICK-SET 80/9 PCC MECA
• MDR Report Key: 11241534
• MDR Text Key: 229813929
• Report Number: 3003442380-2021-00118
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• 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

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2023
• Device Model Number: MMT-386
• Device Lot Number: 5310556
• Date Manufacturer Received: 03/23/2021
• Patient Sequence Number: 1