LYME EV

Description of Event or Problem

NEGATIVE RESULT WAS OBTAINED AND AS A RESULT PT GOT FLU LIKE SYMPTOMS PAIN, MEMORY LOSS, CONFUSION, SLEEP DISTURBANCE, FATIGUE, AND VISUAL PROBLEM. SHE SAID THERE IS ONLY ONE HOSPITAL IN UK THAT IS ALLOWED TO DO THIS TEST AND MUST BE APPROVED BY FDA. SHE WANTS TO KNOW WHY IT IS REQUIRED TO BE FDA APPROVED IN OTHER COUNTRY NOT IN THE U.S.A. AS SHE HAS ALREADY CONTACTED SOME LABS HERE IN US LEARNING THAT THEY ARE PRACTICING WITHOUT HAVING TO GET FDA APPROVAL. SHE ALSO STATED THAT THERE ARE MANY OTHER PTS IN ANOTHER COUNTRY, WHO GOT INCORRECT RESULTS AND SUFFERING SOME BAD CONSEQUENCES. FOLLOWING IS THE DEVICE INFO PROVIDED BY THE REPORTER: DIASORIN LIAISON SYSTEM BASED ON EUROPEAN TRAIN. IGG IMMUNE BLOOD. TRINITY BILTECH MARDX. LYME EU. VIRAM EDIGG. VIRALOT SYSTEM.