MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 46/6 PCC

Lot Number	UNKNOWN
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the cannula was coming out and did not noticed it had come out.Patient's blood glucose level went up to 1125 mg/dl.The patient was hospitalized due to high blood glucose level for 11 days.Currently, patient's blood glucose level was 139 mg/dl.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 46/6 PCC
• MDR Report Key: 8535355
• Report Number: 3003442380-2019-01142
• Device Sequence Number: 16233384
• Product Code: FPA
• UDI-Device Identifier: 05705244005495
• UDI-Public: 05705244005495
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1