VIDAS LYME IGM

Description of Event or Problem

A CUSTOMER CONTACTED BIOMERIEUX REGARDING A (B)(6) RESULT ASSOCIATED WITH A NATIONAL QUALITY CONTROL ((B)(6)) EXERCISE PERFORMED IN (B)(6) 2014. THE IGM RESULT FOR THIS SAMPLE WAS EXPECTED TO BE (B)(6) . THE VIDAS LYME IGM TEST, REF. (B)(4) GAVE A (B)(6) RESULT WHILE THE REAGENTS FOR OTHER COMPANIES GAVE THE EXPECTED (B)(6) RESULT. (B)(6) IS AN EXTERNAL QUALITY CONTROL SCHEME ORGANIZED BY (B)(6) ON AN ANNUAL BASIS. IT CONSISTS OF SEVERAL BLIND SAMPLES WHICH ARE TESTED BY DIFFERENT CUSTOMERS ON THE SAME TECHNIQUE WITH THE AIM OF COMPARING THE RESULTS AND VALIDATE THE TECHNIQUE. THE L3 SAMPLE OF THE NATIONAL QUALITY CONTROL ((B)(6)) EXERCISE IS COMPOSED OF LYOPHILIZED PLASMA OF ONE PATIENT. THE VIDAS LYME IGM (LYM) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS FAMILY OF 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. THE REPORTED VIDAS LYME IGM, REF. (B)(4) , IS NOT SOLD OR DISTRIBUTED WITHIN THE UNITED STATES; HOWEVER, A SIMILAR VIDAS LYME IGM ASSAY, REF (B)(4) , IS SOLD AND DISTRIBUTED WITHIN THE UNITED STATES. AN INVESTIGATION WAS INITIATED AND THE (B)(6) RESULT WAS CONFIRMED WHEN TESTED WITH 2 DIFFERENT LOT NUMBERS OF THE REAGENT DAS LYME IGM. AN INTERFERENCE BETWEEN THE REAGENT AND THE SAMPLE L3 IS SUSPECTED. A SUBSEQUENT CAPA HAS BEEN INITIATED TO DETERMINE THE EXACT ROOT CAUSE AND PROPOSE CORRECTIVE / PREVENTIVE ACTIONS. THE CAPA IS ONGOING AND FURTHER TESTING IS PLANNED TO UNDERSTAND THE ROOT CAUSE OF THE ISSUE. THE MOST PROBABLE ROOT CAUSE IS A CROSS-REACTIVITY INTERFERENCE OF THE VIDAS LYME IGM REAGENT WITH THE SERUM IN SAMPLE L3. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), COSS-REACTIVITY MAY BE OBSERVED WITH CERTAIN DISEASES.