BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTI DX THERMAL CYCLER

    MDR report key: 3949765 · Received May 2, 2014

    Report

    Report Number
    3003673482-2014-00010
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Product Code
    OUL
    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 IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORPORATION AND REPAIRED BY REPLACING THE POWER AMP BOARD. AFTER REPAIR THE UNIT WAS TESTED AND PASSED PERFORMANCE SPECIFICATIONS. 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 0X8007" COMING FROM THE INSTRUMENT, VERITI DX THERMAL CYCLER (CAT NO. 4452300, SERIAL NO. (B)(4)). NO PATIENT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NO. IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265266 VERTI DX THERMAL CYCLER THERMOCYCLER, GENERIC OUL LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1