inforMED
InjuryLSR

TWO-TIER LYME DISEASE TESTING

Received Aug 27, 2014 · Event occurred Mar 18, 2014

Report MW5038013 · MDR key 4059171

Device

Generic name

Lyme Test

Product problems

  • False Negative Result

Patient

6 YR

  • Bacterial Infection
  • Disability
  • No Code Available

Narrative

Description of Event or Problem

DUE TO THE TWO-TIER LYME DISEASE TESTING PROTOCOL, I WENT UNDIAGNOSED FOR 14 YEARS AND GAVE BIRTH TO A CONGENITAL LYME INFECTED CHILD. THIS REPORT IS FOR HER. SINCE THE TESTING GUIDELINES WERE CHANGED FROM THE FLAGELLIN METHOD OR SERIAL TESTING FOR CHANGING ANTIBIOTICS, THE REPORTED CASE NUMBERS HAVE BEEN ARTIFICIALLY LOW, CAUSING DOCTORS TO BELIEVE THEY SHOULD NOT TEST FOR LYME. SINCE I WENT UNDIAGNOSED FOR SO LONG, MY CHILD MUST NOW SUFFER WITH LIFELONG ILLNESS.