ICD-11 code : XE4X1;
Preferred Label : Testing of device from other lot or batch returned from user;
ICD-11 definition : The investigation employed relevant empirical testing of the device of another lot
or batch than that of the suspected device in the reported adverse event in order
to support the identification of possible causes for the adverse event. This includes
devices without a lot/batch designation. The device was returned from the user. Relevant
testing would typically be based on test methods used for evaluating safety and performance
as described in the technical file. Relevant testing would typically be based on test
methods used for evaluating safety and performance as described in the latest relevant
standards.;
Origin ID : 1796949879;
Automatic exact mappings (from CISMeF team)
The investigation employed relevant empirical testing of the device of another lot
or batch than that of the suspected device in the reported adverse event in order
to support the identification of possible causes for the adverse event. This includes
devices without a lot/batch designation. The device was returned from the user. Relevant
testing would typically be based on test methods used for evaluating safety and performance
as described in the technical file. Relevant testing would typically be based on test
methods used for evaluating safety and performance as described in the latest relevant
standards.
