BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7500 FAST DX REAL-TIME PCR INSTRUMENT

    MDR report key: 3915637 · Received June 11, 2014

    Report

    Report Number
    3003673482-2014-00016
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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

    IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS REPAIRED BY REPLACING THE MAIN CONTROLLER BOARD. AFTER REPAIR THE UNIT WAS TESTED AND PASSED PERFORMANCE SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST X 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

    DURING THE OPERATIONAL QUALIFICATION OF THE 7500 FAST DX REAL-TIME PCR INSTRUMENT (CATALOG NO. 4406985, SERIAL NO. (B)(4)), THE CUSTOMER AND FIELD SERVICE ENGINEER OBSERVED POPPING SOUNDS AND A BURNING SMELL. NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344471 7500 FAST DX REAL-TIME PCR INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPL NSU LIFE TECHNOLOGIES HOLDINGS PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1