MAUDE Adverse Event Report: VARISOFT; COMFORT 60/17 TCAP

Lot Number	5191628
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.It was reported that the tubing of one of the infusion sets disconnected from the plastic pitchfork that allowed for the connection to patient's site.At the time of this event, patient's blood glucose level was at 178 mg/dl.The patient did not notice any damage when the package was first opened.No further information available.

• Brand Name: VARISOFT
• Common Device Name: COMFORT 60/17 TCAP
• MDR Report Key: 8511990
• Report Number: 8021545-2019-00125
• Device Sequence Number: 1921383
• Product Code: FPA
• UDI-Device Identifier: 05705244014787
• UDI-Public: 05705244014787
• 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: 07/01/2020
• Device Lot Number: 5191628
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/13/2019
• Patient Sequence Number: 1