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

Lot Number 5270033

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient's infusion set's tubing had disconnected at the tubing connector.Reportedly, the patient blood glucose level was normal and did not require any medical treatment.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: 9514411
• MDR Text Key: 183279483
• Report Number: 3003442380-2019-01987
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2022
• Device Lot Number: 5270033
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1