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

Model Number	MMT-866
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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 experienced high blood glucose level close to 400 mg/dl as the infusion set's tubing had detached at the site portion, while sitting when the patient was at work.The site location was patient's right stomach area above navel as the patient had pain/discomfort on the side location of the stomach and the pump was located at the right side.Moreover, the infusion had been used for a day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, they were unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, the patient's blood glucose level was 125 mg/dl.No further information available.
Event or Problem Description
On (b)(6) 2020: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the all test results were within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced high blood glucose level close to 400 mg/dl as the infusion set's tubing had detached at the site portion, while sitting when the patient was at work.The site location was patient's right stomach area above navel as the patient had pain/discomfort on the side location of the stomach and the pump was located at the right side.Moreover, the infusion had been used for a day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, they were unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, the patient's blood glucose level was 125 mg/dl.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: CONTACT DETACH G29 80/6 PCC
• MDR Report Key: 9754916
• Report Number: 3003442380-2020-00186
• Device Sequence Number: 14004467
• 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,Followup

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: 08/01/2022
• Device Model Number: MMT-866
• Device Lot Number: 5295172
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1