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

Model Number	MMT-866
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that the new infusion set's tubing disconnected at the tubing connector.Therefore, the patient's blood glucose level was normal and did not required medical treatment.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/6 PCC MIMX
• MDR Report Key: 11594422
• Report Number: 3003442380-2021-00196
• Device Sequence Number: 19889739
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• 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: 05/01/2023
• Device Model Number: MMT-866
• Device Lot Number: 5320293
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1