BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978867 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00017
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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 ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE DESIGN ISSUE WHICH PREVENTED THE CUSTOMER FROM OBTAINING RESULTS AFTER A RUN. TO BY-PASS THE SOFTWARE ISSUE, THE FIELD APPLICATION SPECIALIST INSTRUCTED THE CUSTOMER ON HOW TO USE THE "IMPORT FROM FILE" FUNCTION IN THE SOFTWARE. THIS ALLOWED THE CUSTOMER TO OBTAIN RESULTS AFTER THE RUN. THE SOFTWARE ISSUE HAS BEEN ADDRESSED AND A NEW VERSION OF THE SOFTWARE IS SCHEDULED FOR RELEASE. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS 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 LABORATORY TECHNIQUES, PROCEDURES AND ON USE OF THE ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED POOR DATA OBTAINED FROM A RUN USING THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT (CATALOG NO. 4407205 SERIAL NO. (B)(4)). DATA WAS WAVY AND HAD LARGE GAPS IN AMPLIFICATION PLOT. NO PT INVOLVEMENT WAS REPORTED. THE COMPANY EVENT TRACKING NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377258 APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENTATION FOR CLINICAL MULTIP NSU LIFE TECHNOLOGIES HOLDINGS PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1