MAUDE Adverse Event Report: VARISOFT; COMFORT SHORT 80/13 TCAP

Lot Number	5239830
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
(b)(4).Event occurred in the united states.The patient reported that her infusion set tubing broke from where it is attached to the site connecter.It appeared that the adhesive that connects the tubing to the site failed.The patient's blood glucose level was 198 mg/dl at the time of the event.The infusion set tubing was not pulled.She changed the infusion set tubing to resolve the issue.No further information available.

• Brand Name: VARISOFT
• Common Device Name: COMFORT SHORT 80/13 TCAP
• MDR Report Key: 8276827
• Report Number: 8021545-2019-00105
• Device Sequence Number: 2357774
• Product Code: FPA
• UDI-Device Identifier: 05705244014725
• UDI-Public: 05705244014725
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• 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: 05/01/2021
• Device Lot Number: 5239830
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1