VIDAS CMV IGG 60 TESTS

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED. INVESTIGATION RESULTS: FINDINGS FROM PAST INVESTIGATION. DESPITE NUMEROUS TESTS, THE ISSUE WAS NEVER REPRODUCED INTERNALLY. THE INVESTIGATORS HAVE WORKED ON CUSTOMERS¿ MATERIAL (FULL SYSTEM BACK-UP, CONCERNED PATIENTS¿ SAMPLES, CUSTOMER¿S REAGENTS). THE PROBLEM OCCURS RANDOMLY AT SEVERAL CUSTOMERS¿ SITES. TO DATE BIOMÉRIEUX IS STILL MONITORING THE INCIDENCE OF THIS ISSUE. AS THE SOFTWARE DELIVERS INVALID RESULTS, THERE IS NO RISK OF FALSE RESULTS AND THE POTENTIAL IMPACT WOULD BE DELAY OF RESULT IF USER CANNOT GET VALID RESULTS WITH REPEATED TESTS, OR WHEN USER HAD NO ALTERNATIVE SOLUTION IN SHORT TIME. DESPITE THE ROOT CAUSE NOT BEING IDENTIFIED, AS AN IMPROVEMENT, LOGS WILL BE ADDED TO HAVE MORE INFORMATION INTO THE NEXT VERSION OF VIDAS 3 SOFTWARE (VERSION 1.4). THIS VERSION WILL ALSO EMBED SOFTWARE CHANGE TO IMPROVE BEHAVIOR AND WORKAROUND THE CONSEQUENCE OF THE PROBLEM. THE NEW SOFTWARE VERSION CAN BE IMPLEMENTED AT THE CUSTOMER SITE. CONCLUSION: NO ROOT CAUSE IDENTIFIED. THE ISSUE IS NOT REPRODUCED INTERNALLY. THERE IS NO INCREASING NUMBER OF COMPLAINTS FOR SIMILAR ISSUES.

Description of Event or Problem

ON 08-AUG-2021, A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF ERROR MESSAGE (ERROR 3004XSFT1: "SAMPLE OVER DILUTED") LEADING TO DELAYED RESULTS WHEN TESTING WITH VIDAS® CMV IGG (REF. 30204, LOT # 1008656030, EXPIRY DATE: 18-FEB-2022) WITH PATIENT SAMPLES ON THE VIDAS 3 INSTRUMENT (REF. 412590, SERIAL NUMBER (B)(4)). THE ISSUE HAS BEEN RECORDED 3 TIMES BY THE CLIENT OVER THE LAST WEEK. THE VIDAS® IS USED BY THE CLIENT FOR CONFIRMATION OF ANOTHER METHOD RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. NOTE: REFERENCE 30204 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30204-01.