ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT

Additional Manufacturer Narrative

ILLUMINA INTERNAL REFERENCE#: (B)(4). SALESFORCE CASE#: (B)(4). NO HARM OR INJURY WAS REPORTED TO THE USER. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS INCIDENT IS BEING REPORTED DUE TO HAVING THE POTENTIAL TO LEAD TO HARM WHICH MAY CAUSE MEDICAL INTERVENTION IF IT WERE TO REOCCUR. 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 PART IS FROM THE NEXTSEQ 500/550 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) 2026, A CUSTOMER REPORTED EXPOSURE TO THE NEXTSEQ 500/550 BUFFER CARTRIDGE REAGENT. DURING DELIVERY, THE USER DROPPED THE PACKAGED CARTRIDGE FROM A REPORTEDLY LOW HEIGHT AND THE BUFFER REAGENT CONTENTS LEAKED ON TO THE USER'S ARM. IT IS CURRENTLY UNKNOWN IF THE USER WAS WEARING PPE. THE USER DID NOT REPORT ANY ISSUES FOLLOWING EXPOSURE AND FOLLOWED UP WITH THEIR INTERNAL OCCUPATIONAL HEALTH DEPARTMENT. NO HARM OR INJURY WAS REPORTED TO THE USER. WHILE NO DEATH OR SERIOUS INJURY OCCURRED, THIS INCIDENT IS BEING REPORTED DUE TO HAVING THE POTENTIAL TO LEAD TO HARM WHICH MAY CAUSE MEDICAL INTERVENTION IF IT WERE TO REOCCUR.