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

Model Number MMT-397

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

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) 2021, the patient's wife reported that while the patient was working outdoor, the infusion set's tubing got pulled out at the quick release.The site location was patient's abdomen and the pump was at the side.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.The pump was not dropped with the set connected to patient's body.Currently, his blood glucose level was 88 mg/dl.No further information available.

Event Description

On 15-jun-2021: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigations) visual inspection and tests for static pull of tubing-tubing/pcap connector were performed on the returned used device (one set) which 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 (b)(6).On (b)(6) 2021, the patient's wife reported that while the patient was working outdoors, the infusion set's tubing got pulled out at the quick release.The site location was patient's abdomen and the pump was at the side.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.The pump was not dropped with the set connected to patient's body.Currently, his blood glucose level was 88 mg/dl.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: UNO QUICK-SET 60/9 PCC MECA
• MDR Report Key: 11654772
• MDR Text Key: 247578637
• Report Number: 3003442380-2021-00210
• 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

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMT-397
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/03/2021
• Patient Sequence Number: 1