BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPENGENE DAN SEQUENCING SYSTEM

    MDR report key: 2932330 · Received January 22, 2013

    Report

    Report Number
    3003932969-2013-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MZP
    PMA / PMN Number
    BK120013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT HAS BEEN IN USE FOR THREE YEARS. FOR MEDICAL DEVICE REPORTING PURPOSES, THIS EVENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DURING AN ELECTROPHORESIS RUN ON THE TRUGENE LONG READ TOWER SEQUENCER, A COMPONENT OF THE OPENGENE DNA SEQUENCING SYS, THE OPERATOR OBSERVED A FLAME AND SMOKE ON THE INSTRUMENT. NO INJURIES WERE REPORTED. NO RESULTS WERE REPORTED AFTER THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31631 OPENGENE DAN SEQUENCING SYSTEM TRUGENE LONG-READ TOWER SEQUENCER MZP SIEMENS HEALTHCARE DIAGNOSTICS 10312303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other