MAUDE Adverse Event Report: SURE-T PARADIGM; CONTACT DETACH G29 80/8 PCC

Model Number	MMT-876
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.It was reported that the patient's infusion set's tubing detached at the site connector.The site location was his right side of abdomen and the pump was also located on the right side of abdomen.Moreover, the infusion had been in use for one day.Reportedly, the infusions were stored in normal airconditioned space.There was not any stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, (on the day of this report (b)(6) 2020), the patient's blood glucose level was 280 mg/dl.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: CONTACT DETACH G29 80/8 PCC
• MDR Report Key: 10424489
• Report Number: 3003442380-2020-00356
• Device Sequence Number: 2949403
• Product Code: FPA
• UDI-Device Identifier: 05705244006072
• UDI-Public: 05705244006072
• 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 Expiration Date: 12/01/2022
• Device Model Number: MMT-876
• Device Lot Number: 5300559
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1