BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITI DX THERMAL CYCLER

    MDR report key: 3831906 · Received March 6, 2014

    Report

    Report Number
    3003673482-2014-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 3, 2014
    Manufacturer
    LIFE TECHNOLOGIES HOLDING 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 IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORPORATION ON (B)(4) 2014 AND WAS REPAIRED BY REPLACING THE HEATED COVER. AFTER THE HEATED COVER WAS REPLACED, THE INSTRUMENT PASSED ALL THE CALIBRATION AND PERFORMANCE SPECIFICATIONS. THE INSTRUMENT WAS RETURNED TO THE CUSTOMER. 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 "FATAL ERROR/UNRECOVERABLE ERROR OX8013" COMING FROM THE INSTRUMENT, VERITI DX THERMAL CYCLER (CAT NO. 4452300, SERIAL NO. (B)(4)). NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134524 VERITI DX THERMAL CYCLER OUL, 862.2170 NSU LIFE TECHNOLOGIES HOLDING PTE. LTD 299120143

    Patients

    Seq Age Sex Outcome Treatment
    1