BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITI DX THERMAL CYCLER

    MDR report key: 3663884 · Received December 23, 2013

    Report

    Report Number
    3003673482-2013-00041
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    October 1, 2013
    Report Date
    November 29, 2013
    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 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. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORPORATION ON (B)(4) 2013 AND WAS REPAIRED BY REPLACING THE HEATED COVER. AFTER THE HEATED COVER WAS REPLACED THE INSTRUMENT WAS RETURNED TO THE CUSTOMER. THIS IS THE INITIAL AND FINAL REPORT FOR THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE INSTRUMENT VERITI DX THERMAL CYCLER (CATALOGUE NO. 4452300 SERIAL NO. (B)(4)) WAS HAVING AN ERROR MESSAGE - 'ERROR CODE OX8013.' NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673659 VERITI DX THERMAL CYCLER OUL 862.2170 NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD 299120046

    Patients

    Seq Age Sex Outcome Treatment
    1