VIDAS® LYME IGM

Additional Manufacturer Narrative

A CUSTOMER FROM THE UNITED STATES HAD NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH THE VIDAS® LYME IGM INVOLVING A PATIENT SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE PATIENT SAMPLE WAS NOT SUBMITTED FOR EVALUATION. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR VIDAS LYME IGM II LOT 1005662400 /180708 0 SHOWED NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. THE ANALYSIS OF CONTROL CHARTS OF EIGHT (8) INTERNAL SAMPLES, ONE (1) NEGATIVE, TWO (2) EQUIVOCAL, FIVE (5) POSITIVE, ON EIGHT (8) VIDAS LYME IGM II BATCHES (INCLUDING THE LOT MENTIONED BY THE CUSTOMER) SHOWED THAT ALL THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS LYME IGM II LOT 1005662400 /180708 0 IS IN THE TREND OF THE OTHER BATCHES. THE COMPLAINT LABORATORY TESTED FIVE INTERNAL SAMPLES, FOUR (4) POSITIVE AND ONE (1) NEGATIVE, ON A RETAIN KIT OF VIDAS LYME IGM II LOT 1005662400 /180708 0. THE RESULTS OBTAINED WERE WITHIN THE EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED DURING RELEASE. THERE IS NO DRIFT OF VIDAS LYME IGM II LOT 1005662400 /180708 0 SINCE ITS RELEASE. AS IT WAS NOT POSSIBLE TO GET THE SAMPLE, NO FURTHER INVESTIGATION COULD BE PERFORMED. VIDAS LYME IGM II LOT 1005662400 /180708 0 PERFORMED WITHIN THE EXPECTED SPECIFICATIONS.

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH THE VIDAS® LYME IGM INVOLVING A PATIENT SAMPLE. THE CUSTOMER INDICATED RUNNING THE PATIENT SAMPLE AND GETTING NEGATIVE RESULT; HOWEVER, THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE THE WESTERN BLOT WAS POSITIVE FOR MULTIPLE BANDS. THE CUSTOMER REPORTED THE SPECIMEN THEY TESTED AND THE SPECIMEN THE REFERENCE LAB TESTED WERE OBTAINED FROM THE PATIENT AT THE SAME TIME BUT WERE IN DIFFERENT TUBES. SERUM WAS USED FOR BOTH TESTS. THE CUSTOMER INDICATED NEITHER SPECIMEN IS AVAILABLE FOR SUBMISSION TO BIOMÉRIEUX.. A BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.