BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

    MDR report key: 3949740 · Received May 2, 2014

    Report

    Report Number
    3003673482-2014-00009
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Product Code
    OOI
    PMA / PMN Number
    K123955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE. THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE DESIGN ISSUE WHICH PREVENTED THE CUSTOMER FROM OBTAINING RESULTS AFTER A RUN. TO BY-PASS THE SOFTWARE ISSUE, THE FIELD APPLICATION SPECIALIST INSTRUCTED THE CUSTOMER ON HOW TO USE THE "IMPORT FROM FILE" FUNCTION IN THE SOFTWARE. THIS ALLOWED THE CUSTOMER TO OBTAIN RESULTS AFTER THE RUN. THE SOFTWARE ISSUE HAS BEEN ADDRESSED AND A NEW VERSION OF THE SOFTWARE IS SCHEDULED FOR RELEASE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SOFTWARE BUG WHICH RESULTED IN INCORRECT SAMPLE IDENTIFICATION. WHEN ONE SAMPLE ON A PLATE WAS ASSIGNED A NEW IDENTIFIER, THE REST OF THE SAMPLES ON THE PLATE WERE AUTOMATICALLY RENAMED. ADDITIONALLY, A POP-UP ERROR MESSAGE APPEARED ON THE SCREEN. THE MEDICAL DEVICE INVOLVED WAS QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (CATALOG NO. 4484383, 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
    265384 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT REAL TIME NUCLEIC ACID AMPLIFICATION OOI LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1