InjuryLSR
ELISA TEST SYSTEM
Received Nov 30, 2015 · Event occurred Jan 8, 2013
Report MW5058271 · MDR key 5264050
Device
Generic name
Elisa Test System
Product problems
- False Negative Result
Patient
42 YR
- No Code Available
Narrative
Description of Event or Problem
I TOOK THE LYME ELISA TEST IN (B)(6) 2012 AND THE TEST CAME BACK NEGATIVE. BECAUSE OF THIS, I STOPPED EVEN CONSIDERING LYME DISEASE AND STARTED SEARCHING OTHER PATHS. I FINALLY TOOK A WESTERN BLOT TEST FOR LYME DISEASE IN (B)(6) 2013 AND WAS CDC POSITIVE. THE DELAY IN GETTING MY DIAGNOSIS EXACERBATED MY SYMPTOMS AND MADE ME MISS MANY MONTHS OF WORK.