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) 2021, it was reported that the patient's infusion set's tubing came apart at the quick release while the patient was sleeping.The site location was patient's abdomen, and the pump was on the same side in relation to the site.Moreover, the infusion had been used for one day.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 300 mg/dl.No further information available.
Event or Problem Description
On 10-mar-2022: follow up information was submitted to add date of this report and to update the awareness date.Moreover, the result of complaint investigation of returned used device (one set), showed that the tubing was detached from the tubing connector and excess of glue was noticed where tubing was joined on the tubing connector.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On 19-aug-2021, it was reported that the patient's infusion set's tubing came apart at the quick release while the patient was sleeping.The site location was patient's abdomen, and the pump was on the same side in relation to the site.Moreover, the infusion had been used for one day.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 300 mg/dl.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: UNO CONTACT DETACH G29 60/8 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12411857
• Report Number: 3003442380-2021-00416
• Device Sequence Number: 19727119
• 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,Followup
• Report Date (Section B): 03/10/2022

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
• Device Expiration Date: 02/01/2023
• Device Model Number: MMT-874
• Device Lot Number: 5311000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown