Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date 05/15/2018
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
Customer¿s husband reported via phone call that insulin was squirting out during manual process.The customer¿s blood glucose level was 140 mg/dl at the time of the incident.Customer states they were not wearing the pump during priming.There was no gap between the piston and reservoir stopper during prime.The insulin pump will not be returned for analysis.