Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date 08/28/2018
Event Type
malfunction
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event Description
The customer reported via phone call that they had infusion set leak.The customer¿s blood glucose level was unknown at the time of the incident.Customer was advised the infusion set will be replaced.The infusion set will not be returned for analysis.