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	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On 30-nov-2020, it was reported that the patient's infusion set's tubing had detached from the connecter in the morning when the patient woke up.Reportedly, her blood glucose level was 280 mg/dl.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 80/6 PCC MIMX
• MDR Report Key: 10973069
• Report Number: 3003442380-2020-00471
• Device Sequence Number: 834832
• 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: 11/01/2022
• Device Model Number: MMT-866
• Device Lot Number: 5300552
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1