BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMINA MISEQDX INSTRUMENT

    MDR report key: 23023144 · Received September 10, 2025

    Report

    Report Number
    3005095756-2025-00001
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ILLUMINA HAYWARD
    Product Code
    PFF
    UDI-DI
    00816270020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ILLUMINA INTERNAL REFERENCE # (B)(4), SALESFORCE CASE # (B)(4). IT WAS A MINOR BURN AND THE FSE DID NOT REQUIRE MEDICAL ATTENTION. NO HARM, DEATH, OR SERIOUS INJURY WAS REPORTED. THIS 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 · 0

    THE IMPACTED PRODUCT IS THE MISEQ SYSTEM, WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS LIKE OR SIMILAR TO THE MISEQDX 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 MISEQDX INSTRUMENT IS INTENDED FOR TARGETED SEQUENCING OF DNA LIBRARIES FROM HUMAN GENOMIC DNA EXTRACTED FROM PERIPHERAL WHOLE BLOOD OR FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) TISSUE, WHEN USED WITH IN VITRO DIAGNOSTIC (IVD) ASSAYS PERFORMED ON THE INSTRUMENT. THE MISEQDX INSTRUMENT IS NOT INTENDED FOR WHOLE GENOME OR DE NOVO SEQUENCING. THE MISEQDX INSTRUMENT IS TO BE USED WITH REGISTERED AND LISTED, CLEARED, OR APPROVED IVD REAGENTS AND ANALYTICAL SOFTWARE. ON AUGUST 20, 2025, AN ILLUMINA FIELD SAFETY ENGINEER (FSE) WAS AT THE CUSTOMER SITE TO PERFORM OPTICAL ADJUSTMENT WHILE INSTALLING A NEW SOLID STATE DRIVE (SSD). DURING INSTALLATION, THE FSE OBSERVED SMOKE AND BROWN DISCOLORATION ON THE CABLE AS WELL AS A BURNT HOLE IN THE BLACK OUT CLOTH. THE SOURCE WAS TRACED TO A FLOW SENSOR CABLE. THE CABLE WAS THEN UNPLUGGED AND THE INSTRUMENT WAS SHUT DOWN IMMEDIATELY PER FIELD INSTRUCTIONS. THE FSE CONFIRMED THAT THEY BURNED THEIR HAND WHEN DISCONNECTING THE CABLE. IT WAS A MINOR BURN AND THE FSE DID NOT REQUIRE MEDICAL ATTENTION. NO HARM, DEATH, OR SERIOUS INJURY WAS REPORTED. PLEASE NOTE: IN A STANDARD LAB SETTING, THE FLOW SENSOR CABLE IS CONTAINED WITHIN A FIRE BOX WITHIN THE INSTRUMENT. THEREFORE, A LAB OPERATOR WOULD NOT BE EXPOSED TO THIS TYPE OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675657 ILLUMINA MISEQDX INSTRUMENT ILLUMINA MISEQDX INSTRUMENT PFF ILLUMINA HAYWARD N/A N/A 00816270020002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other