inforMED
InjuryLSR

ELISA - LYME DISEASE

Received Aug 31, 2014 · Event occurred Feb 6, 2007

Report MW5038073 · MDR key 4064373

Device

Generic name

Elisa - Lyme Disease

Product problems

  • False Negative Result

Patient

52 YR

  • Cyst(s)
  • Fatigue
  • Headache
  • Hearing Impairment
  • Inflammation
  • Menstrual Irregularities
  • Respiratory Distress
  • Seizures
  • Tissue Damage
  • Arthralgia
  • Malaise
  • Irritability
  • Encephalitis
  • Cognitive Changes
  • No Code Available

Narrative

Description of Event or Problem

I FELT ILL ON (B)(6) 2006. MY PRIMARY CARE PHYSICIAN DID HIS BEST TO HELP ME, RUNNING MANY TESTS. IN (B)(6) I HAD A BULL'S EYE RASH FROM AN UNOBSERVED TICKBITE, LATER DETERMINED TO HAVE BEEN A REINFECTION BY CLINICAL DIAGNOSIS. MY DOCTOR HERE IN (B)(6) DID NOT RECOGNIZE THE EM RASH EVEN THOUGH IT WAS A CLASSIC BULL'S EYE. HE CONTINUED TO RUN TESTS AND SEND ME TO SPECIALISTS. IN (B)(6) 2007 I WAS GIVEN AN ELISA TEST FOR LYME, WHICH WAS NEGATIVE AND SO HE CONSIDERED LYME TO BE RULED OUT (ALONG WITH (B)(6)). I WAS NOT AWARE OF THIS TEST AT THE TIME (I WAS EXTREMELY SICK WITH COGNITIVE IMPAIRMENT). FINALLY, IN (B)(6), I DECIDED IT WAS LIKELY THAT I HAD LYME AND ASKED FOR A WB. THAT TEST WAS POSITIVE, THOUGH NOT CDC POSITIVE. I WAS FINALLY ABLE TO GET TREATMENT FOR A LATE STAGE DISEASE THAT LEFT ME FULLY DISABLED BECAUSE IT HAD BEEN ALLOWED TO PROGRESS FOR SO LONG. I LATER REALIZED THAT, HAD MY DOCTOR BEEN ABLE TO RECOGNIZE THE EM RASH, I WOULD HAVE BEEN DIAGNOSED IN (B)(6) 2006 INSTEAD OF DIAGNOSING MYSELF IN (B)(6) 2007. CLEARLY, THE ELISA WAS A FALSE NEGATIVE. CLEARLY, I HAD LYME DISEASE DESPITE A WB THAT WAS NOT CDC POSITIVE. BOTH THE ELISA AND ALL WB TESTS THAT INSIST ON USING CDC SURVEILLANCE CRITERIA AS "POSITIVE" ARE DEFECTIVE. THUS I HAVE TWO COMPLAINTS. THE ELISA TEST RETURNED A FALSE NEGATIVE AND DELAYED MY DIAGNOSIS FOR 5 EXCRUCIATING MONTHS. ANY WB THAT RELIES UPON THE CDC CASE DEFINITION FOR SURVEILLANCE TO DEFINE A POSITIVE TEST RESULT, DOES NOT COMPLY WITH THE CDC DIRECTIVE THAT IT IS NOT TO BE USED FOR DIAGNOSIS. I HAVE PERSONAL DAMAGE DUE TO ITEM ONE. DURING THE 13 MONTH DELAY, I HAD TACHYCARDIA (ER VISIT), MIGRAINES (ER VISIT), RADICULONEUROPATHY, ENCEPHALITIS, FROZEN SHOULDER, AN UNNECESSARY COLONOSCOPY, SEIZURES, PARKINSONS-LIKE MOVEMENT DISORDER, CALF MUSCLE ATROPHY, THENAR ATROPHY (BOTH HANDS), JOINT PAIN EVERYWHERE, TENDONITIS (MULTIPLE LOCATIONS), COGNITIVE IMPAIRMENT, AUDITORY HYPERACUSIS, SEVERE IRRITABILITY, GI CHANGES, FALLOPIAN TUBE CYST, SUDDEN MENOPAUSE AND PRE-CANCEROUS CELLS (CERVIX) REQUIRING SURGICAL PROCEDURE, POST EXERTIONAL MALAISE, SEVERE FATIGUE. THESE ARE JUST THE WORST ASPECTS OF MY EXPERIENCE. WHILE AN INCORRECT TEST RESULT ONLY DELAYED MY DIAGNOSIS BY 5 MONTHS, IT WAS STILL WRONG AND RESULTED IN MORE SUFFERING THAN I WOULD HAVE SUFFERED OTHERWISE.