inforMED
InjuryLSR

LYME ANTOBODY TEST

Received Sep 6, 2014 · Event occurred Jan 15, 2009

Report MW5038139 · MDR key 4080891

Device

Generic name

Lyme Test

Product problems

  • Incorrect Or Inadequate Test Results

Patient

31 YR

  • Emotional Changes
  • Fatigue
  • Headache
  • Hearing Loss
  • Neuropathy
  • Pain
  • Rash
  • Loss of Vision
  • Misdiagnosis

Narrative

Description of Event or Problem

I WAS BIT BY A TICK, LIVING IN (B)(6), IN 2008 AND DEVELOPED A BULLS EYE RASH WITH LYME SYMPTOMS. SIX MONTHS LATER, I WAS TESTED FOR LYME DISEASE WITH TWO TIER TESTING - ELISA AND WESTERN BLOT. THE TESTS WERE NEGATIVE AND I RECEIVED NO TREATMENT. OVER THE NEXT SIX YEARS MY LYME SYMPTOMS GRADUALLY BECAME DRASTICALLY WORSE TO THE POINT WHERE I CANNOT WORK DUE TO SEVERE COGNITIVE SYMPTOMS, FATIGUE NEUROPATHY, JOINT PAIN, INTERMITTENT VISION AND HEARING LOSS AND MIGRAINES. I NOW HAVE A POSITIVE TWO TIER TEST BY CDC STANDARDS. THE INACCURACY OF THIS TESTING LED TO DELAYED TREATMENT AND FULLY DISSEMINATED LYME DISEASE. HAD I TESTED POSITIVE WITH THE FIRST TEST, I COULD HAVE BEEN CURED WITH A FEW MONTHS OF LOW COST ANTIBIOTICS. LATE STAGE LYME DISEASE HAS COST ME MY JOB ((B)(6)) AND I NOW SPEND (B)(6) PER MONTH OUT OF POCKET FOR THE PORTION OF THE TREATMENT MY HEALTH INSURANCE DOES NOT COVER. FORTUNATELY, I HAVE A GREAT INSURANCE THAT COVERS THE OTHER (B)(6) PER MONTH. I AM NOT A RARE CASE. THE INACCURACY OF THE LYME TESTING IS ACKNOWLEDGED BY THE CDC. PLEASE HELP TO FIX THIS TESTING. WITH AN ESTIMATED 1 MILLION NEW CASES OF LYME DISEASE EACH YEAR, TESTING INACCURACY HAS DIRE CONSEQUENCES; INCLUDING PERSONAL LOSSES BOTH EMOTIONAL AND FINANCIAL, INCREASED MEDICAL COSTS AND AN ECONOMIC IMPACT FROM DECREASED WORKER PRODUCTIVITY.