BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3500 XL DX GENETIC ANALYZER CS2

    MDR report key: 3831934 · Received March 6, 2014

    Report

    Report Number
    3003673482-2014-00004
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 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. IT WAS DISCOVERED THAT THE ARRAY DOOR WAS BINDING, PREVENTING THE LASER TO PASS THROUGH CAPILLARY. THE DOOR/SPRING WAS DISASSEMBLED AND LUBRICATED. IT WAS THEN REASSEMBLED AND INSTALLED. SEVERAL SPATIAL CALIBRATIONS WERE RUN AFTER THE REPAIR AND THE INSTRUMENT PASSED REQUIRED SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 DX SERIES SOFTWARE 2011 (VL) ARE INVITRO DIAGNOSTIC DEVICES INTENDED FOR THE SEQUENCING (DETECTION AND IDENTIFICATION) OF FLUORESCENTLY-LABELED DEOXYRIBONUCLEIC ACID (DNA) BY CAPILLARY ELECTROPHORESIS. THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 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 THERE WAS SPATIAL CALIBRATION FAILURE IN THE INSTRUMENT, 3500 XL DX GENETIC ANALYZER CS2 (CAT. NO. 4461444, SERIAL NO. (B)(4)). NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134547 3500 XL DX GENETIC ANALYZER CS2 PCA PCA LIFE TECHNOLOGIES HOLDINGS PTE. LTD 25800-221

    Patients

    Seq Age Sex Outcome Treatment
    1