VIDAS® CMV IGG

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ISRAEL OF OBSERVING DELAYED RESULTS ON 4 PATIENT SAMPLES, DUE TO MISSING SPRS, WHEN USING VIDAS® CMV IGG 60 TESTS, LOT 1008757110, EXPIRY DATE = 15-APR-2022). INVESTIGATION: DEVICE HISTORY RECORD AND COMPLAINT ANALYSIS THE ANALYSIS OF THE BATCH HISTORY RECORD FOR THE VIDAS CMV IGG REF 30204 LOT 1008757110 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO NON-CONFORMITY NOR CAPA IS LINKED TO THE CUSTOMER¿S COMPLAINT RECORDED ON VIDAS CMV IGG REF 30204 LOT 1008757110. THERE IS NO OTHER SIMILAR COMPLAINT ON VIDAS CMV IGG REF 30204 LOT 1008757110 ANALYSES WERE DONE ON RETAINED KIT VIDAS CMV IGG REF 30204 LOT 1008757110. THE INVESTIGATION LABORATORY VERIFIED THE NUMBER OF SPRS PER POUCH OF KIT VIDAS CMVG REF 30204 LOT 1008757110. THE TWO POUCHES CONTAIN 30 SPRS EACH. ANALYSIS OF THE MANUFACTURING AND PACKAGING FILES, CARRIED OUT BY THE INDUSTRIALIZATION DEPARTMENT, SHOWED NO ANOMALIES. CONCLUSION: CUSTOMER ANOMALY WAS NOT REPRODUCED WITH THE RETAIN KIT. THE ISSUE OBSERVED BY CUSTOMER MAY BE LINKED TO INTERNAL OPERATOR ERROR DURING THE PACKAGING PROCESS. BASED ON INVESTIGATION FINDINGS, THERE IS NO RECONSIDERATION ON VIDAS® CMV IGG REF 30204 LOT 1008757110 PERFORMANCE.

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBSERVING DELAYED RESULTS ON 4 PATIENT SAMPLES WHEN USING VIDAS CMV IGG 60 TESTS, LOT 1008757110, EXPIRY DATE = 15-APR-2022. THERE WERE SPRS MISSING IN TWO KITS OF VIDAS CMV IGG 60 TESTS, LOT 1008757110: ONE SPR MISSING IN THE FIRST KIT, AND FIVE SPRS MISSING IN THE SECOND KIT. AS A CONSEQUENCE OF THIS ISSUE, THE CUSTOMER WAS UNABLE TO PROCEED WITH TESTING AND THERE WERE DELAYED RESULTS OF OVER 24 HOURS FOR 4 PATIENTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL INVESTIGATION WAS INITIATED.