BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCR

    MDR report key: 3978863 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00021
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE REPAIR COMPLETED BY REPLACING HEATER COVER. THE INSTRUMENT PASSED ALL SPECIFICATION TESTS AFTER THE HEATER COVERED WAS REPLACED. THIS DEVICE IS USED TO OBTAIN RESULTS FOR A DIAGNOSIS. 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 THE 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 CONTAMINATION ON HEATER COVER ON THE INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4406985) WITH SERIAL NO. (B)(4), RESULTING IN INCORRECT RESULTS REPORTED FOR AN ASSAY RUN. NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378387 APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCR INSTRUMENTATION FOR CLINICAL MULTIPLEX NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1