inforMED
InjuryNPQ

ILLUMINA TEST KIT

Received Aug 15, 2017 · Event occurred Aug 5, 2017

Report MW5071604 · MDR key 6800095

Device

Generic name

Conductance Regulator Gene, Variant. Gene, Sequence Detection

Manufacturer

Illumina Inc.

Product problems

  • Insufficient Device Problem Information

Patient

32 YR

  • No Code Available
  • No Code Available

Narrative

Description of Event or Problem

RECEIVED GENETIC REPORT FROM ILLUMINA SEQUENCING ASSAY WHICH INCORRECTLY IDENTIFIED HEALTH DISORDERS IMPACTING GENETIC COUNSELING GUIDANCE.