ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT

Description of Event or Problem

THE IMPACTED PRODUCT IS THE NEXTSEQ 550 SEQUENCING SYSTEM (15067451) AND SERIAL NUMBER (B)(4), WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS SIMILAR TO THE NEXTSEQ¿ 550DX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). THE NEXTSEQ¿ 550DX INSTRUMENT IS INTENDED FOR SEQUENCING DNA LIBRARIES WITH IN VITRO DIAGNOSTIC ASSAYS. FOR ITS INPUT, THE NEXTSEQ¿ 550DX USES LIBRARIES GENERATED FROM DNA WHERE SAMPLE INDEXES AND CAPTURE SEQUENCES ARE ADDED TO AMPLIFIED TARGETS. SAMPLE LIBRARIES ARE CAPTURED ON A FLOW CELL AND SEQUENCED ON THE INSTRUMENT USING SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY. SBS CHEMISTRY USES A REVERSIBLE-TERMINATOR METHOD TO DETECT FLUORESCENTLY LABELED SINGLE NUCLEOTIDE BASES AS THEY ARE INCORPORATED INTO GROWING DNA STRANDS. THE SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY FOR THE RUO INSTRUMENT IS SIMILAR TO THE IVD INSTRUMENT, THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. NOTE: INDIVIDUAL FORMULATIONS MAY DIFFER SOMEWHAT. ON (B)(6) 2021, A CUSTOMER, (B)(6), REPORTED THAT AFTER COMPLETION OF THE SEQUENCING RUN ON ILLUMINA NEXTSEQ 550 INSTRUMENT (RUO), A PURPLE SOLUTION WAS FOUND ON THE FLOOR. THE LABORATORY WAS EVACUATED. THE SAFETY TEAM WAS ON SITE AND CLEANED THE FLOOR. A FEW MEMBERS FROM THE LABORATORY TEAM COMPLAINED OF SORE THROAT AND TIGHT CHEST. FIRST AID RESPONDERS EXAMINED THE LABORATORY TEAM AND CONFIRMED THE TEAM TO BE DOING WELL AND THAT THE TEAM DID NOT NEED FURTHER EVALUATION. ILLUMINA HAS WORKED WITH THE CUSTOMER IN THE INVESTIGATION TO FIND THE ROOT CAUSE. THE ILLUMINA FIELD TEAM WAS ON SITE AND THE INVESTIGATION REVEALED THAT THE MOST LIKELY ROOT CAUSE WAS THE FAULTY WASTE BOTTLE SENSOR. THE SENSOR IS PERMANENTLY IN THE WASTE BOTTLE PRESENT POSITION AND DOESN'T SPRING BACK ONCE THE WASTE BOTTLE IS REMOVED. THIS COULD EXPLAIN HOW A LEAK COULD HAVE HAPPENED. ILLUMINA WILL REPLACE THE FAULTY SENSOR ON THE NEXTSEQ 550 INSTRUMENT (RUO) AT THE CUSTOMER SITE AND CONTINUE TO WORK\ WITH THE CUSTOMER IN THE INVESTIGATION. AN ILLUMINA FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND TESTED THE WASTE BOTTLE PRESENT SENSOR AND FOUND IT IS PERMANENTLY IN THE "WASTE BOTTLE PRESENT" POSITION AND DOES NOT SPRING BACK ONCE THE WASTE BOTTLE IS REMOVED. THE FSE REPLACED THE WASTE BOTTLE PRESENT SENSOR. THE AFFECTED INSTRUMENT WAS PUT BACK INTO SERVICE AND IS FUNCTIONING AS INTENDED. ILLUMINA IS PLANNING TO UPDATE THE NEXTSEQ 550DX INSTRUMENT PREVENTIVE MAINTENANCE GUIDE TO INCLUDE STEPS FOR THE FSE TO CHECK THE WASTE BOTTLE PRESENT SENSOR. ILLUMINA WILL CONTINUE TO MONITOR FIELD COMPLAINTS TO ENSURE NO RECURRENCE OF WASTE LEAK ON NEXTSEQ 550DX INSTRUMENT IS DUE TO A FAULTY WASTE BOTTLE PRESENT SENSOR.

Additional Manufacturer Narrative

ILLUMINA INTERNAL REFERENCE # (B)(4). SALESFORCE CASE # (B)(4). THIS REPORT WAS PREVIOUSLY SUBMITTED ON (B)(6) 2021 UNDER MFR REPORT # 7102730-2021-00001. A RECEIPT OF SUBMISSION WAS RECEIVED BY ILLUMINA. HOWEVER, WHEN ILLUMINA WENT TO SUBMIT FOLLOW-UP FINAL REPORTING, THE SYSTEM WAS UNABLE TO LINK/LOCATE THE INITIAL SUBMISSION. THEREFORE, THIS REPORT IS BEING SUBMITTED AS AN INITIAL/FINAL REPORT AND THERE WILL BE NO FURTHER REPORTING UNLESS ILLUMINA RECEIVES NEW OR ADDITIONAL REPORTABLE INFORMATION.