XE1XT

ICD-11 MMS 2026-01

Testing of model variant

Description

The investigation employed relevant empirical testing of a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.

Index terms

  • Testing of model variant

Sibling codes

  • XE18W – Device discarded
  • XE2ZR – Testing of device from other lot batch retained by manufacturer
  • XE3TW – Insufficient information available
  • XE4KV – Analysis of production records
  • XE4S0 – Testing of device from same lot batch returned from user
  • XE4X1 – Testing of device from other lot or batch returned from user
  • XE53L – Device not accessible for testing
  • XE59M – Analysis of data provided by user or third party
  • XE5AN – Incomplete device returned
  • XE6FS – Testing of patient sample or reference material using manufacturer's device
  • XE6Q2 – Type of investigation not yet determined
  • XE7GK – Communication or interviews
  • XE7XH – Testing of device from same lot or batch retained by manufacturer
  • XE89L – Testing of patient sample or reference material using competitor's device
  • XE8BM – Trend analysis
  • XE8FB – Device not manufactured by reporting manufacturer
  • XE8UH – Historical data analysis
  • XE8XV – Testing of raw or starting materials
  • XE970 – Device not returned
  • XE9HD – Testing of actual or suspected device
  • XE9MY – Testing of patient sample or reference material using reference method

Foundation entity

Testing of model variant – http://id.who.int/icd/entity/1886547997

Part of: X: Extension Codes