MAUDE Adverse Event Report: SURE-T PARADIGM; CONTACT DETACH G29 60/6 PCC

Model Number	MMT-864
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 on (b)(6) 2020 at 9:00 pm, the patient was admitted to the intensive care unit due to diabetic ketoacidosis and high blood glucose level of 26.5 mmol/dl, due to leakage in the infusion set.Reportedly, the leak was 15 cm from the reservoir and there was a cut in the tubing, but the tubing did not come apart.During hospitalization, the patient received intravenous drip (drug name unknown).As per report dated, (b)(6) 2020 at 3:57 pm, the patient was still in the hospital.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: CONTACT DETACH G29 60/6 PCC
• MDR Report Key: 10131986
• Report Number: 3003442380-2020-00293
• Device Sequence Number: 3220682
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• 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 Model Number: MMT-864
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1