BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3978888 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00018
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 7, 2013
    Report Date
    March 7, 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 FIELD SVC ENGINEER ATTRIBUTED THE CONTAMINATION ISSUE TO WEAR AND TEAR OF THE HEATED COVER. THE HEATED COVER WAS REPLACED AND THE CONTAMINATION ISSUE WAS RESOLVED. 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 (B)(6) FIELD SVC ENGINEER REPORTED THAT CONTAMINATION FROM THE HEATED COVER OF APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT (CATALOG NO. 4407205 SERIAL NO. (B)(4)) CAUSED INCORRECT RESULTS TO BE REPORTED FROM A RUN. WE WERE NOT MADE AWARE OF ANY IMPACT TO PT MANAGEMENT. THE COMPANY EVENT TRACKING NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377149 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