BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITI DX THERMAL CYCLER

    MDR report key: 3623818 · Received December 9, 2013

    Report

    Report Number
    3003673482-2013-00008
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 20, 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. BASED ON INVESTIGATION CONDUCTED, THE INSTRUMENT GIVES AN ERROR ONCE IT REACHED 95 DEGREES C. IT WAS TESTED WITH WORKING CONTROLLER PCA AND IT WORKED. THE REPAIR WAS COMPLETED BY REPLACING THE CONTROLLER PCA. 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) WITH SERIAL NO. (B)(4) WAS HAVING A 'ERROR - SET POINT FAILURE' MESSAGE. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639716 VERITI DX THERMAL CYCLER OUL 862.2170 NSU LIFE TECHNOLOGIES HOLDINGS PTE. LTD. 299120182

    Patients

    Seq Age Sex Outcome Treatment
    1