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

Lot Number	UNKNOWN
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 in the morning of (b)(6) 2019, she received an alert for high blood glucose level and then she noticed that the infusion set's tubing had detached from the tubing connector, while sleeping.The site location was the back of her arm and the pump was in the side pocket.The infusion had been in used for one day.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 the patient's body.No further information available.
Event or Problem Description
On 18-dec-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the tubing was detached from the tubing connector.Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that in the morning of (b)(6) 2019, she received an alert for high blood glucose level and then she noticed that the infusion set's tubing had detached from the tubing connector, while sleeping.The site location was the back of her arm and the pump was in the side pocket.The infusion had been in used for one day.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 the patient's body.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 80/8 PCC
• MDR Report Key: 9345851
• Report Number: 3003442380-2019-01931
• Device Sequence Number: 16201738
• 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,Followup

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1