BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

    MDR report key: 3978988 · Received June 27, 2014

    Report

    Report Number
    3003673482-2014-00012
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE AND WAS REPAIRED BY REPLACING THE LAMP AND MOTOR CONTROLLER BOARD. AFTER REPLACEMENT, FUNCTIONAL TESTS WERE PERFORMED TO VERIFY THE INSTRUMENT FUNCTIONALITY. DEVICE INTENDED USE: THE QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT WITH QUANTSTUDIO DX SOFTWARE IS INTENDED TO PERFORM FLUORESCENCE-BASED PCR TO PROVIDE DETECTION FO FDA CLEARED AND APPROVED NUCLEIC ACID SEQUENCES IN HUMAN-DERIVED SPECIMENS. THE QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT WITH QUANTSTUDIO DX SOFTWARE IS INTENDED FOR IN VITRO DIAGNOSTIC USE BY TRAINED LAB TECHNOLOGISTS IN COMBINATION WITH NEUCLEIC ACID REAGENT KITS/TESTS MANUFACTURED AND LABELED FOR DIAGNOSTIC PURPOSES ON THIS INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LAMP ERROR AND INSTRUMENT FAILED SELF TEST THAT WOULD CAUSE A RUN TO NOT START OR NOT GENERATE RESULTS AFTER ASSAY COMPLETION. THE MEDICAL DEVICE INVOLVED WAS QUANSTUDIO DX REAL-TIME PCR INSTRUMENT (CAT # 4470660, SERIAL# (B)(4)). NO PT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NUMBER IS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378374 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT REAL TIME NUCLEIC ACID AMPLIFICATION OOI LIFE TECHNOLOGIES HOLDINGS PTE., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1