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

Lot Number	5278544
Medical Device Problem Code	Material Deformation (2976)
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 (b)(6).It was reported that a child patient experienced high blood glucose level of 600 mg/dl.The patient took 12 units of insulin but that did not work, so 12 units of insulin were taken again.Subsequently, in the morning of (b)(6) 2019, the patient was hospitalized, and it was stated that the catheter had a hole and it was leaking.Therefore, insulin was coming out of the tubing.No alarms found on the pump according to nurse.Reportedly, the patient was still hospitalized at the time of this report on 29 oct-2019.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 80/6 PCC
• MDR Report Key: 9392209
• Report Number: 3003442380-2019-01945
• Device Sequence Number: 13870988
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• 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 Expiration Date: 06/01/2022
• Device Lot Number: 5278544
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/30/2019
• Patient Sequence Number: 1