block
Cause investigation and type of investigation
Definition
For describing what was investigated and what kind of investigation was conducted to specify the root cause of the adverse event.
22 subordinate codes
XE9HDTesting of actual or suspected deviceXE7XHTesting of device from same lot or batch retained by manufacturerXE4S0Testing of device from same lot batch returned from userXE2ZRTesting of device from other lot batch retained by manufacturerXE4X1Testing of device from other lot or batch returned from userXE1XTTesting of model variantXE8XVTesting of raw or starting materialsXE6FSTesting of patient sample or reference material using manufacturer's deviceXE9MYTesting of patient sample or reference material using reference methodXE89LTesting of patient sample or reference material using competitor's deviceXE8UHHistorical data analysisXE8BMTrend analysisXE7GKCommunication or interviewsXE4KVAnalysis of production recordsXE59MAnalysis of data provided by user or third partyXE8FBDevice not manufactured by reporting manufacturerXE970Device not returnedXE18WDevice discardedXE5ANIncomplete device returnedXE53LDevice not accessible for testingXE6Q2Type of investigation not yet determinedXE3TWInsufficient information available