BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCR

    MDR report key: 3978856 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00027
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 24, 2013
    Report Date
    April 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPAIR COMPLETED BY CHANGING THE LAMP AND PERFORMING OPTICAL ALIGNMENT AND RE-OPTICAL CALIBRATION. THE REPAIRED INSTRUMENT PASSED ALL SPECIFICATIONS. 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 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 NOISY AMPLIFICATION PLOT AND COMPONENT PLOT ON THE INSTRUMENT APPLIED BIOSYSTEM 7500 FAST DX (CAT NO. 4407205) WITH SERIAL NO. (B)(4), RESULTING IN INCORRECT, WAVY RESULTS. NO PT INVOLVEMENT REPORTED. COMPANY EVENT TRACKING NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377627 APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCR INSTRUMENTATION FOR CLINICAL MULTIPL NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1