BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978848 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00033
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 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 BY REPLACING THE HEATED COVER. 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 THERE WAS APPARENT FAILED AMPLIFICATIONS OF FALSE NEGATIVE IN WELL E2. THE INSTRUMENT INVOLVED WAS APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4407205, SERIAL NO. (B)(4). NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378385 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