MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 46/6 PCC

Lot Number	5198458
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.The patient reported that she had an infusion set that detached at clear tubing cap when she was getting ready for shower with blood glucose level going up to 300 mg/dl.The site location was at the stomach and the pump was on the same side.Reportedly, the infusions were stored in a room.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.In the investigation, it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 46/6 PCC
• MDR Report Key: 8576885
• Report Number: 3003442380-2019-01431
• Device Sequence Number: 13869861
• Product Code: FPA
• UDI-Device Identifier: 05705244005495
• UDI-Public: 05705244005495
• 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: 07/01/2020
• Device Lot Number: 5198458
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1