Device Problem
Appropriate Term/Code Not Available (3191)
Patient Problem
Insufficient Information (4580)
Event Date 08/06/2019
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.This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.
Event Description
The customer reported via phone call that their insulin pen only worked half the time they have used it.Customer¿s blood glucose was unknown.No harm requiring medical intervention was reported.The insulin pen will not be returned for analysis.