BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

    MDR report key: 3623826 · Received December 9, 2013

    Report

    Report Number
    3003673482-2013-00007
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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 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. LIFE TECHNOLOGIES' FIELD SAFETY ENGINEER (FSE) REVIEWED THE DATA, INSPECTED OPTICS AND RAN DIAGNOSTICS. RE-SEATED THE LAP, RAN THERMAL CYCLER DIAGNOSTICS AND RNASE P PLATE TO VERIFY. INSTRUMENT MEETS INSTALLATION SPECIFICATION. THE REPAIR CONDUCTED WAS RE-SEATING OF THE LAMP ONLY. THIS IS THE INITIAL AND FINAL REPORT OF THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS NO AMPLIFICATION IN THE INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4407205) WITH SERIAL NO. (B)(4). NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639896 APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR NSU 862.2570 NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD. 275030503

    Patients

    Seq Age Sex Outcome Treatment
    1