VIDAS LYME IGM ASSAY

Additional Manufacturer Narrative

INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. REVIEW OF MANUFACTURING QUALITY CONTROL RECORDS CONFIRMED ALL LOTS OF VIDAS LYME IGM PERFORMED IN ACCORDANCE WITH SPECIFICATIONS UPON PRODUCT RELEASE. RECENT CAP AND LAB QUALITY SURVEYS INDICATE ACHIEVEMENT OF THE EXPECTED RESULTS FOR VIDAS LYME IGM. ADDITIONAL TESTING WITH SIEMENS ENZYGNOST BORRELIOSIS IGM PROVIDES THE EXPECTED RESULT OF "NEGATIVE". THE INVESTIGATION REPRODUCED A PERCENTAGE OF "EQUIVOCAL" AND "POSITIVE" RESULTS AS IDENTIFIED BY THE VIDAS LYME IGM CUSTOMER AGAINST THE NATIONAL CONTROL WIV N°6749. BASED ON THE LAST (B)(6) CONTROL SURVEY, PRESENCE OF RHEUMATOID FACTOR IN THE SAMPLE IS SUSPECTED AS THE LIKELY CAUSE. IN ADDITION, PRODUCT LIMITATIONS DESCRIBED IN THE VIDAS LYME IGM PACKAGE INSERT INDICATE: POSITIVE RESULTS IN THE VIDAS LYME IGG AND IGM ASSAY MUST BE INTERPRETED WITH CAUTION. CROSS-REACTIVITY MAY BE OBSERVED WITH CERTAIN DISEASES. CLINICAL SYMPTOMS, EPIDEMIOLOGICAL INFORMATION AND OTHER LABORATORY TEST RESULTS MUST ALL BE CONSIDERED IN ADDITION TO VIDAS LYME IGM AND IGG ASSAY RESULTS. INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. TESTING SHOULD BE DONE ONLY WHEN EXPOSURE HISTORY, EPIDEMIOLOGY AND CLINICAL SYMPTOMS SUGGEST LYME DISEASE. BASED ON THE RESULTS OF THE INVESTIGATION, VIDAS LYME IGM IS PERFORMING IN ACCORDANCE WITH THE SPECIFICATIONS/LIMITATIONS INDICATED IN THE PACKAGE INSERT. ALL OTHER TEST METHODS AND SURVEYS REVIEWED DURING THE INVESTIGATION INDICATE NO ANOMALY LINKED TO A LOT OR LOTS OF THE VIDAS LYME IGM ASSAY.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A SAMPLE OF THE EXTERNAL QUALITY CONTROL OF THE (B)(4) FAILED FOR THE VIDAS LYME IGM TEST (REF. 30319, LOT 1003590580, EXPIRY 27OCT15). THE TEST RESULTED IN A "POSITIVE" RESULT WITH A VALUE OF 0.36 INSTEAD OF THE EXPECTED RESULT OF "NEGATIVE". THE VIDAS LYME IGM ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS FAMILY INSTRUMENTS, FOR THE DETECTION OF IGM ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN HUMAN SERUM OR PLASMA, TO AID IN THE DIAGNOSIS OF LYME DISEASE. THERE WAS NO DEATH, SERIOUS INJURY OR ADVERSE EVENT REPORTED AS A RESULT OF THE DISCREPANT RESULT. VIDAS LYME IGM PRODUCT REFERENCE 30319 IS NOT MARKETED OR SOLD IN THE UNITED STATES. HOWEVER, THE SIMILAR VIDAS LYME IGM II ASSAY (REF. 416436) IS SOLD IN THE UNITED STATES. QUALITY CONTROL SAMPLE SUBMITTALS HAVE BEEN REQUESTED FOR INTERNAL INVESTIGATION.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.