VIDAS® LYME IGG

Additional Manufacturer Narrative

AN INVESTIGATION INTO A (B)(6) RESULT EVENT WHILE USING THE VIDAS® LYME IGG TEST KIT WAS PERFORMED. THE CUSTOMER OBTAINED A (B)(6) RESULT WITH THE VIDAS® LYME IGG TEST KIT. TESTING AT A REFERENCE LAB BY WESTERN BLOT PROVIDED A (B)(6) RESULT. THE PATIENT SAMPLE WAS NOT RETURNED FOR INVESTIGATIONAL TESTING; THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED. THREE QUALITY CONTROL SAMPLES NEAR THE CUTOFF VALUE WERE RUN ON RETAIN SAMPLES FROM THE LOT INVOLVED WITHIN THIS COMPLAINT. ALL RESULTS WERE WITHIN EXPECTED VALUES. A REVIEW OF THE BATCH PRODUCTION RECORD AND ORIGINAL QUALITY CONTROL RELEASE TESTING WAS PERFORMED. NO RELATED ANOMALIES OR ABNORMALITIES WERE FOUND. BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PRODUCT IS OPERATING WITHIN SPECIFICATIONS.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE VIDAS LYME IGG ASSAY. THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY; TESTING VIA WESTERN BLOT (WB) METHOD PROVIDED A POSITIVE RESULT. ALL RESULTS WERE PROVIDED TO THE TREATING PHYSICIAN. THE CUSTOMER WAS NOT ABLE TO PROVIDE INFORMATION REGARDING THE CLINICAL STATUS OF THE PATIENT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER STATED THE SAMPLE IS NO LONGER AVAILABLE. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.