BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978858 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00026
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Product Code
    NSU
    PMA / PMN Number
    K082562
    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 FIELD SERVICE ENGINEER VISUALLY INSPECTED THE DEVICE AND FOUND THAT THE CONNECTOR AND CABLE PLUG HAD BURN MARKS. THE FSE REPLACED THE LAMP CABLE AND CONTROLLER BOARD. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS SOFTWARE VERSION 1.4 IS AN REAL-TIME NUCLEIC ACID AMPLIFICATION AND DETECTION SYSTEM THAT MEASURES NUCLEIC ACID SIGNALS FROM REVERSE TRANSCRIBED RNA AND CONVERTS THEM TO COMPARATIVE QUANTITATIVE READOUTS USING FLUORESCENT DETECTION OF DUAL-LABELED HYDROLYSIS PROBES. THE 7500 FAST DX REAL-TIME PCR INSTRUMENT IS TO BE USED ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND ON USE OF THE ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT (CATALOG NO. 4407205 SERIAL NO. (B)(4) SHOWS HIGH BACKGROUND IN THE AMPLIFICATION PLOT RESULTS. WE WERE NOT MADE AWARE OF ANY IMPACT TO PT MANAGEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377255 APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTTRUMENTATION FOR CLINICAL MULTIPL NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1