inforMED
MalfunctionLSR

ELISA FOR LYME DISEASE

Received Nov 17, 2014

Report MW5039185 · MDR key 4270729

Device

Generic name

Elisa For Lyme Disease

Product problems

  • False Negative Result

Patient

54 YR

  • Misdiagnosis
  • Disability

Narrative

Description of Event or Problem

FOLLOWING TICK BITS IN (B)(6) I DEVELOPED A COMPLEX ARTHRALGIC, FIBROMYALGIC, CHRONIC FATIGUE SYNDROME LIKE ILLNESS WITH SEVERE NEUROLOGICAL COMPROMISE. MY DOCTOR CONSIDERED LYME AND TICK BORNE DISEASES AT THE TOP OF THE DIFFERENTIAL DIAGNOSTIC CAUSES. TRYING TO GIVE HISTORY, HE REASSURED HE WOULD DO THE TEST IE: ELISA FIRST AND W BLOT IF DIRECTED BY ELISA. TEST WAS NEGATIVE. SURVEILLANCE CRITERIA WERE APPLIED BY MY ILLNESS RESULTING IN 2-3 YEAR DELAY IN DIAGNOSIS, SUFFERING AND DISABILITY. LONG, LONG, LONG TERM RX HAS RESULTED IN RETURN TO QUALITY OF LIFE WITH CONTINUED TREATMENT. THIS COULD BE AVOIDED BY CORRECT INFORMATION TO PATIENTS THAT THE TEST WHEN NEGATIVE, A PATIENT CAN STILL HAVE LYME DISEASE. THEN GETTING MORE TESTING AT MY COST WOULD HAVE BEEN A DOOR OPENED, NOT CLOSED BY EXAGGERATED ACCURACY OF THE ELISA "SCREENING" TEST. A TEST WHICH QUALIFIES BY MEASURING ITSELF IN OTHER SAMPLES. GO FIGURE.