BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3500 XL DX GENETIC ANALYZER CS2

    MDR report key: 3815366 · Received March 27, 2014

    Report

    Report Number
    3003673482-2014-00007
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Product Code
    PCA
    PMA / PMN Number
    BK110039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE. THE INVESTIGATION DETERMINED THE CAUSE OF THE AIR BUBBLES WAS DUE TO A LEAKING PUMP. THE PUMP WAS REPLACED AND SPATIAL CALIBRATION WAS RUN AFTER THE REPAIR. THE INSTRUMENT PASSED REQUIRED SPATIAL CALIBRATION SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 DX SERIES SOFTWARE 2011 (VL) ARE IN VITRO DIAGNOSTIC DEVICES INTENDED FOR THE SEQUENCING (DETECTION AND IDENTIFICATION) OF FLUORESCENTLY LABELED DEOXYRIBONUCLEIC ACID (DNA) BY CAPILLARY ELECTROPHORESIS. THE APPLIED BIOSYSTEMS 3500XL DX SEQUENCING ASSAYS SPECIFYING THEIR USE AND ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND USE OF THE ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE 3500XL DX GENETIC ANALYZER CS2 (CAT NO 4461444, SERIAL NO (B)(4)) STOPPED IN THE MIDDLE OF AN ASSAY RUN DUE TO THE PRESENCE AIR BUBBLES. NO PATIENT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181768 3500 XL DX GENETIC ANALYZER CS2 DNA GENETIC ANALYZER PCA LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1