ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT

Additional Manufacturer Narrative

ILLUMINA INTERNAL REFERENCE # (B)(4). SALESFORCE CASE # (B)(4). ON (B)(6) 2022, A CUSTOMER REPORTED THAT AFTER THE RUN WAS COMPLETED ON THEIR NEXTSEQ 500, THE WASTE HAD LEAKED AS THE WASTE BOTTLE WAS NOT PLACED CORRECTLY DURING THE RUN. NO HARM OR INJURY WAS REPORTED, BUT THE CUSTOMER REPORTED BEING CONCERNED ABOUT SLIPPING ON THE WASTE LIQUID AS WELL AS EXPOSURE TO THE HARMFUL COMPONENTS OF THE NEXTSEQ RUN SPILLED OVER THE FLOOR. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS IS A REPEAT OF THE ISSUE PREVIOUSLY REPORTED UNDER MFR # 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 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 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) 2022, A CUSTOMER REPORTED THAT AFTER THE RUN WAS COMPLETED ON THEIR NEXTSEQ 500, THE WASTE HAD LEAKED AS THE WASTE BOTTLE WAS NOT PLACED CORRECTLY DURING THE RUN. NO HARM OR INJURY WAS REPORTED, BUT THE CUSTOMER REPORTED BEING CONCERNED ABOUT SLIPPING ON THE WASTE LIQUID AS WELL AS EXPOSURE TO THE HARMFUL COMPONENTS OF THE NEXTSEQ RUN SPILLED OVER THE FLOOR. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS IS A REPEAT OF THE ISSUE PREVIOUSLY REPORTED UNDER MFR # AND IS BEING REPORTED DUE TO HAVING THE POTENTIAL TO LEAD TO HARM WHICH MAY CAUSE MEDICAL INTERVENTION.