MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/6 PCC

Model Number MMT-866

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that he woke with high blood glucose levels of 407 mg/dl.Moreover, he noticed air bubbles in the reservoir (basal).Reportedly, the infusion set's tubing had detached at the quick release.Further, he also stated that there was blood coming up the tube from the body but was no longer bleeding.Upon investigation, of the returned used device (1 set), it was noticed that the tubing was detached from the tubing connector.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Type of Device: CONTACT DETACH G29 80/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9851804
• MDR Text Key: 184071672
• Report Number: 3003442380-2020-00212
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• Combination Product (y/n): N
• 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: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMT-866
• Device Lot Number: 5218983
• Date Manufacturer Received: 06/21/2018
• Type of Device Usage: N
• Patient Sequence Number: 1