MAUDE Adverse Event Report: VARISOFT; COMFORT SHORT 110/13 TCAP

Lot Number	5191631
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 in the middle of the night, the tubing detached approximately 6 inches below the connector needle and the same issue occurred the following morning.The patient was unsure about how it happened.Patient's blood glucose level was in 300 mg/dl range on both occasions.The patient changed the infusion set and resumed insulin.The patient did not notice any damage when the package was first opened.No further information available.

• Brand Name: VARISOFT
• Common Device Name: COMFORT SHORT 110/13 TCAP
• MDR Report Key: 8447323
• Report Number: 8021545-2019-00114
• Device Sequence Number: 16888547
• Product Code: FPA
• UDI-Device Identifier: 05705244014756
• UDI-Public: 05705244014756
• 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: 08/01/2020
• Device Lot Number: 5191631
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1