VIDAS CMV IGG

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING INVALID CMV IGG RESULTS WHEN TESTING PATIENT SAMPLES USING VIDAS® CMV IGG TEST KIT (REF. 30204, LOT 1007989700) AND THE VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL (B)(4)) WITH SOFTWARE VERSION 1.3. A VIDAS SYSTEM MESSAGE INDICATED THAT THE SAMPLE MAY BE OVER-DILUTED WHEREAS THE SERUM WAS NOT DILUTED. BIOMERIEUX CUSTOMER SERVICE REQUESTED DETAILS REGARDING THE DILUTION ERROR OBTAINED BY THE CUSTOMER AND IF THE ERROR LEAD TO ANY DELAY IN REPORTING RESULTS; HOWEVER THE CUSTOMER HAS NOT RESPONDED TO THIS REQUEST. A TASK HAS BEEN CREATED TO UPDATE THE COMPLAINT IF/WHEN THE CUSTOMER PROVIDES THE REQUESTED INFORMATION. THE CUSTOMER CONFIRMED THE RESULTS WERE NOT REPORTED NOR WAS AVIDITY TESTING PERFORMED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE OVER DILUTION ERROR MESSAGE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

AN INVESTIGATION WAS INITIATED AT THE MANUFACTURING SITE FOLLOWING A CUSTOMER FROM BELGIUM NOTIFYING BIOMÉRIEUX OF OBTAINING INVALID RESULTS WITH THE PRODUCT VIDAS®CMV IGG (REF 30204) WHEN USING A VIDAS 3 INSTRUMENT WITH SOFTWARE VERSION 1.3.2. A VIDAS SYSTEM MESSAGE INDICATED THAT THE SAMPLE MIGHT BE TOO OVER-DILUTED WHEREAS THE SERUM WAS NOT DILUTED. FOR THIS ISSUE, NO RESULT IS RELEASED AND A MESSAGE ERROR IS DISPLAYED BY THE SOFTWARE. INVESTIGATION FOLLOWING SEVERAL REQUESTS, THE INVESTIGATION TEAM WAS NOT PROVIDED ANY MATERIAL FROM CUSTOMER (NAMELY EXPORT FILES, DATA BACK UP OR FULL SYSTEM BACK UP). SINCE JANUARY 2020, WE HAVE RECORDED A TOTAL OF 7 COMPLAINTS LINKED TO THE CUSTOMER'S ISSUE (OVER-DILUTED SAMPLE). THE INVESTIGATORS HAVE WORKED ON CUSTOMERS¿ MATERIAL (FULL SYSTEM BACK-UP, CONCERNED PATIENTS¿ SAMPLES, CUSTOMER¿S REAGENTS). DESPITE NUMEROUS TESTS, THE ISSUE WAS NEVER REPRODUCED INTERNALLY. ACCORDING TO THE LAST COMPLAINTS ANALYSIS, THERE HAS BEEN NO NEW COMPLAINT RECORDED FOR OVER-DILUTED ISSUE. BIOMÉRIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE AND DETERMINED THAT THE OVERALL RISK IS IRRELEVANT. 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 A SHORT TIME. DESPITE THE FACT THAT THE ROOT CAUSE WAS NOT IDENTIFIED, BIOMÉRIEUX HAS INITIATED A SOFTWARE CHANGE THAT WILL ADD LOGS FOR A BETTER TRACKING/UNDERSTANDING OF THE ISSUE AND WILL ALLOW A WORK-AROUND FOR THE CONSEQUENCE OF THE PROBLEM.NA.