ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT

Additional Manufacturer Narrative

ILLUMINA INTERNAL REFERENCE # (B)(4). SALESFORCE CASE #(B)(4). ON (B)(6) 2024, A CUSTOMER REPORTED THAT THEY STARTED A RUN ON THEIR NEXTSEQ 500 RUO INSTRUMENT WITH NO WASTE CARTRIDGE LOADED, BUT THE INSTRUMENT FAILED TO DETECT THE MISSING CARTRIDGE. DURING THE ASSAY RUN, THE WASTE MECHANISM IS LOWERED INTO THE SEQUENCE POSITION. ONCE THE OPERATOR NOTICED THE WASTE BOTTLE WAS NOT PRESENT, THE CUSTOMER TRIED TO BYPASS THE LOWERED WASTE MECHANISM BY CUTTING A BUFFER CARTRIDGE AND INSERTING THE BUFFER CARTRIDGE TO COLLECT THE SPENT REAGENT. THE BUFFER CARTRIDGE WAS MET WITH RESISTANCE AND THE OPERATOR PUT THEIR HAND INTO THE INSTRUMENT TO DETERMINE WHAT WAS OBSTRUCTING THE ALTERED BUFFER CARTRIDGE. IN DOING SO, THE OPERATOR'S ARM TOUCHED THE WASTE FLUID. THE OPERATOR WAS WEARING GLOVES AND WASHED THE AFFECTED AREA IMMEDIATELY. NO HARM OR INJURY WAS REPORTED TO THE OPERATOR. THE OPERATOR DID NOT SEEK MEDICAL INTERVENTION. THE INITIAL INVESTIGATION INDICATES THE WASTE SENSOR WAS STUCK IN THE "WASTE BOTTLE PRESENT" POSITION EVEN THOUGH THE WASTE BOTTLE WAS NOT LOADED AT THE START OF THE SEQUENCING RUN. THIS LED THE INSTRUMENT TO BELIEVE THE WASTE BOTTLE WAS PRESENT AND LET THE OPERATOR PROCEED WITH SEQUENCING. THE WASTE SENSOR FOR THE CUSTOMER WAS REPLACED BY AN ILLUMINA FIELD SERVICE ENGINEER (FSE) AND THE ISSUE WAS RESOLVED. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS IS A REPEAT OF THE ISSUE PREVIOUSLY REPORTED UNDER MFR # 3007102730-2021-00001, 3007102730-2022-00001, AND 3007102730-2023-00001 AND IS BEING REPORTED DUE TO HAVING THE POTENTIAL TO LEAD TO HARM WHICH MAY CAUSE MEDICAL INTERVENTION. THIS MEDWATCH IS BEING SUBMITTED AS AN INITIAL AND FINAL MEDWATCH. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED, ILLUMINA WILL SUBMIT A SUPPLEMENTAL MEDWATCH.

Description of Event or Problem

THE IMPACTED PRODUCT IS THE NEXTSEQ 500 SEQUENCING SYSTEM, WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS SIMILAR TO THE NEXTSEQ¿ 550DX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). 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. 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. ON (B)(6) 2024, A CUSTOMER REPORTED THAT THEY STARTED A RUN ON THEIR NEXTSEQ 500 RUO INSTRUMENT WITH NO WASTE CARTRIDGE LOADED, BUT THE INSTRUMENT FAILED TO DETECT THE MISSING CARTRIDGE. DURING THE ASSAY RUN, THE WASTE MECHANISM IS LOWERED INTO THE SEQUENCE POSITION. ONCE THE OPERATOR NOTICED THE WASTE BOTTLE WAS NOT PRESENT, THE CUSTOMER TRIED TO BYPASS THE LOWERED WASTE MECHANISM BY CUTTING A BUFFER CARTRIDGE AND INSERTING THE BUFFER CARTRIDGE TO COLLECT THE SPENT REAGENT. THE BUFFER CARTRIDGE WAS MET WITH RESISTANCE AND THE OPERATOR PUT THEIR HAND INTO THE INSTRUMENT TO DETERMINE WHAT WAS OBSTRUCTING THE ALTERED BUFFER CARTRIDGE. IN DOING SO, THE OPERATOR'S ARM TOUCHED THE WASTE FLUID. THE OPERATOR WAS WEARING GLOVES AND WASHED THE AFFECTED AREA IMMEDIATELY. NO HARM OR INJURY WAS REPORTED TO THE OPERATOR. THE OPERATOR DID NOT SEEK MEDICAL INTERVENTION. THE INITIAL INVESTIGATION INDICATES THE WASTE SENSOR WAS STUCK IN THE "WASTE BOTTLE PRESENT" POSITION EVEN THOUGH THE WASTE BOTTLE WAS NOT LOADED AT THE START OF THE SEQUENCING RUN. THIS LED THE INSTRUMENT TO BELIEVE THE WASTE BOTTLE WAS PRESENT AND LET THE OPERATOR PROCEED WITH SEQUENCING. THE WASTE SENSOR FOR THE CUSTOMER WAS REPLACED BY AN ILLUMINA FIELD SERVICE ENGINEER (FSE) AND THE ISSUE WAS RESOLVED. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS IS A REPEAT OF THE ISSUE PREVIOUSLY REPORTED UNDER MFR # 3007102730-2021-00001, 3007102730-2022-00001, AND 3007102730-2023-00001 AND IS BEING REPORTED DUE TO HAVING THE POTENTIAL TO LEAD TO HARM WHICH MAY CAUSE MEDICAL INTERVENTION.