MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/8 PCC MIMX

Model Number	MMT-874
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.On (b)(6) 2020, it was reported that, last night when the patient went to bed, the infusion set's tubing detached at the tubing connector and noticed it when the patient woke up.The site location was patient's left abdomen and the pump was in the left side.Moreover, the infusion was not used for more than two days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, patient's blood glucose level was 280 mg/dl.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 60/8 PCC MIMX
• MDR Report Key: 10989212
• Report Number: 3003442380-2020-00476
• Device Sequence Number: 17031244
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 06/01/2023
• Device Model Number: MMT-874
• Device Lot Number: 5325102
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1