MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/8 PCC

Lot Number	5156821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that while sleeping, the infusion set's tubing detached.She stated that as she woke up, and found her tubing was detached from her infusion set and noticed that she had high blood glucose level.Reportedly, the blood glucose level was 400 mg/dl currently and at the time of incident.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 60/8 PCC
• MDR Report Key: 8468121
• Report Number: 3003442380-2019-00794
• Device Sequence Number: 1664124
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Lot Number: 5156821
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1