BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978987 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00013
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    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 INSTRUMENT WAS INVESTIGATED ON SITE. PROBLEM SOLVED ON SITE BY REPLACING THE USB ADAPTOR. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE (B)(4) SOFTWARE VERSION 1.4 IS A 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 LAB TECHNIQUES, PROCEDURES, AND ON USE OF THE ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THERE WAS CONNECTION ISSUE IN THE INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CAT # 4407205, SERIAL# (B)(4)) THAT CAUSED THE INSTRUMENT TO STOP IN THE MIDDLE OF AN ASSAY RUN. NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377793 APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENTATION FOR CLINICAL MULTIP NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD,

    Patients

    Seq Age Sex Outcome Treatment
    1