MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC

Lot Number	5263476
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing fell out, as it detached from the quick release while she was sleeping, during the night.Reportedly, she woke up at 2 am with a low blood glucose level but at 4 am her blood glucose level was high.The site location was her upper buttocks and the pump was located beside the bed.The infusion had been in use for one day.There was no stress or pull on the tubing and the pump was not dropped with the set connected to her body.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 80/8 PCC
• MDR Report Key: 9212710
• Report Number: 3003442380-2019-01850
• Device Sequence Number: 10862391
• Product Code: FPA
• UDI-Device Identifier: 05705244006072
• UDI-Public: 05705244006072
• 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

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: 12/01/2021
• Device Lot Number: 5263476
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1