Device Problems
Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)
Patient Problem
Insufficient Information (4580)
Event Date 02/04/2020
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
Customer reported via phone call that the inpen is able to dial up to any amount regardless of how much insulin is left in the cartridge.No harm requiring medical intervention was reported.The device is not expected to return for analysis.