WESTERN BLOT LYME TEST
Received Sep 7, 2014 · Event occurred May 20, 2014
Report MW5038140 · MDR key 4080893
Device
Product problems
- False Positive Result
Patient
71 YR
- No Information
Narrative
Description of Event or Problem
WESTERN BLOT TEST FOR LYME DISEASE INDICATED "PRESENT" FOR IGG P23; "PRESENT" FOR IGM P41; AND "PRESENT" FOR IGM P23. BUT THE TEST WAS LABELLED A "FALSE POSITIVE," BECAUSE A PREVIOUS TEST HAD BEN REQUIRED. THE BLOOD SERUM WAS TAKEN ON (B)(6) 2014 AND THE TEST RESULTS WERE REPORTED ON (B)(6) 2014. TEST RESULTS PROVIDED ON (B)(6) 2014 INDICATED "POSITIVE" AS THE INTERPRETATION FOR THE LYME IGM WB TEST. HOWEVER, THE CDC RULES DID NOT PERMIT A DIAGNOSIS OF LYME ON THE BASIS OF THIS, REQUIRING INSTEAD A TWO-TIERED TESTING PROCESS. THE INFECTIOUS DISEASE DOCTOR DID NOT APPARENTLY HAVE THE AUTHORITY TO DIAGNOSE LYME DISEASE WITH THIS RESTRICTIVE CDC.