BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978836 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00035
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    October 23, 2013
    Report Date
    October 23, 2013
    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. THE FIELD SERVICE ENGINEER (FSE) REMOVED TAPE FROM HEATED COVER AND RUN NEW BACKGROUND, THE PROBLEM WAS SOLVED. 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 HIGH BACKGROUND IN DATA OF THE RESULTS REPORTED WHEN USING APPLIED BIOSYSTEMS 7500 FAST DX (CAT NO 4407205, SERIAL NO (B)(4)." THE HIGH BACKGROUND LED TO INCORRECT ASSAY RESULTS. NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378382 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