VIDAS® LYME IGG

Description of Event or Problem

A CUSTOMER REPORTED TO BIOMERIEUX A DISCREPANT RESULT EVENT OCCURRED WHEN USING THE VIDAS LYME IGG TEST KIT. THE CUSTOMER REPORTED THAT THE VIDAS LYME IGG TEST KIT RETURNED A NEGATIVE RESULT FOR A PATIENT SAMPLE WHEREAS A WESTERN BLOT ON THE SAME SAMPLE RETURNED A POSITIVE RESULT. WHEN SPECIFICALLY ASKED, THE CUSTOMER INDICATED NO ADVERSE IMPACT TO THE PATIENT OR DELAY IN RESULTS WAS EXPERIENCED AS A RESULT OF THIS EVENT. AN INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.

Additional Manufacturer Narrative

AN INVESTIGATION INTO A DISCREPANT RESULT EVENT WHILE USING THE VIDAS® LYME IGG TEST KIT WAS PERFORMED. THE CUSTOMER OBTAINED A NEGATIVE RESULT WITH THE VIDAS® LYME IGG TEST KIT YET THE WESTERN BLOT WAS POSITIVE. AN ANALYSIS OF THE BATCH HISTORY RECORDS SHOWS NO ANOMALY DURING THE CONTROL PROCESS. QUALITY CONTROL SAMPLES NEAR THE CUT OFF OF THE VIDAS® LYME IGG TEST KIT WERE PERFORMED ON RETAIN SAMPLES OF THE LOT IN QUESTION. ALL SAMPLES RETURNED THE EXPECTED RESULTS. THE PERFORMANCE OF THE LOT IN QUESTION HAS NOT CHANGED SINCE ORIGINAL RELEASE TO THE FIELD. TESTING OF THE RETURN PATIENT SAMPLE ON RETAIN SAMPLES FROM THE LOT IN QUESTION AS WELL AS ANOTHER LOT WAS ALSO PERFORMED. BOTH LOTS RETURNED A NEGATIVE RESULT CONSISTENT WITH THE CUSTOMER'S RESULT. THE QUALITY PRODUCT LABORATORY HAS TESTED THE RETURN SAMPLE ON THE RETAIN KIT VIDAS® LYME IGG 1004526300 / 161123-0 AND ON A OTHER RETAIN KIT VIDAS® LYME IGG 1004350980 / 160914-0. A THIRD TECHNIQUE WAS UTILIZED IN CONJUNCTION WITH THE RETURNED PATIENT SAMPLE, ALLDIAG OPTIMACHECK LYME ASSAY (IMMUNOBLOT). THE CUSTOMER'S RETURN SAMPLE WAS TESTED AND GAVE NEGATIVE RESULTS FOR BOTH IGG AND IGM. THE NEGATIVE RESULTS OBTAINED WITH THE ALLDIAG OPTIMACHECK LYME ASSAY (IMMUNOBLOT) WERE IN AGREEMENT WITH THE VIDAS® TECHNIQUE . THE MOST LIKELY ROOT CAUSE IS THAT THE EUROIMMUN TECHNIQUE HAS A HIGHER SENSITIVITY THAN THE ALLDIAG TECHNIQUE AND VIDAS® LYME IGG AS TESTED IN OUR LABORATORY. MOREOVER AS THE PATIENT WAS TREATED, THE DECREASE OF ANTIBODIES WITH NEGATIVE IGM AND A LOW LEVEL OF IGG SHOWS THAT THE TREATMENT IS EFFECTIVE. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PRODUCT IS PERFORMING IN ACCORDANCE WITH THE LIMITATIONS OF THE METHOD.