LYME IGG/IG M AB
Received Feb 6, 2008 · Event occurred Jan 1, 2008
Report MW5005258 · MDR key 996322
Device
Generic name
None
Product problems
- Incorrect Or Inadequate Test Results
Patient
26 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PT REPORTS THAT HE TESTED 2 TIMES FOR LYME'S DISEASE AND RECEIVED A NEGATIVE RESULT. HE TESTED ON A DIFFERENT TEST AND RECEIVED A POSITIVE RESULT. PT STATES THAT ACCORDING TO THE HOSPITAL, STUDIES HAS SHOWN THAT THERE IS A 75% FAILURE RATE WITH THE LYME'S TEST. LYME'S DISEASE IF DETECTED EARLY CAN BE TREATED. HOWEVER, IF LEFT UNDETECTED THEN IT WILL CAUSE HEALTH PROBLEMS IN PATIENTS.