BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITI DX THERMAL CYCLER

    MDR report key: 3835034 · Received March 25, 2014

    Report

    Report Number
    3003673482-2014-00006
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Product Code
    NSU
    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 IT NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORP AND REPAIRED BY REPLACING THE POWER AMP BOARD. AFTER REPAIR, UNIT FUNCTIONAL TEST WAS PERFORMED AND THE INSTRUMENT WORKS AS NORMAL AND THE OVERALL RESULT IS OK. INVESTIGATION IS IN PROCESS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS VERITI DX THERMAL CYCLER AMPLIFIES HUMAN NUCLEIC ACID SAMPLES FOR DIAGNOSTIC APPLICATIONS. THE VERITI DX THERMAL CYCLER IS TO BE USED ONLY BY OPERATORS TRAINED IN LABORATORY TECHNIQUES AND PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ERROR MESSAGE "ERROR 0X006" COMING FROM THE INSTRUMENT, VERITI DX THERMAL CYCLER (CAT NO. 4452300, SERIAL NO. (B)(4)). NO PT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173711 VERITI DX THERMAL CYCLER NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD. 299120179

    Patients

    Seq Age Sex Outcome Treatment
    1