BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000RT

    MDR report key: 2840231 · Received May 1, 2012

    Report

    Report Number
    3005248192-2012-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 2, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL REVIEW BY A PRODUCT SUPPORT ENGINEER DETERMINED THAT THE M 2000RT BLOCK DRIVE ASSEMBLY FAILURE WAS CAUSED BY ELECTRICAL ARCING OR A SHORT CIRCUIT. THE OVERHEATING WAS DUE TO THE THERMAL DEGRADATION OF THE ELECTRICAL COMPONENT AND ASSOCIATED INSULATION WHICH CAUSED A SMALL AMOUNT OF BLACKENING OR SOOT MARKS.

    Description of Event or Problem · 1

    THE ABBOTT M2000RT IS PART OF THE M2000 REALTIME SYSTEM AND IS FOR REAL-TIME PCR AMPLIFICATION AND DETECTION OF NUCLEIC ACIDS. A CUSTOMER IN (B)(6), REPORTED AN ERROR CODE DISPLAY DURING INITIALIZATION OF THE M2000RT INSTRUMENT. THE ABBOTT FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AS A FOLLOW UP TO THE CUSTOMER REPORT AND OBSERVED A CHARRED MARK AND SOME DAMAGED COMPONENTS ON THE BLOCK DRIVE ASSEMBLY INTERFACE. THE FSE REPLACED THE BLOCK DRIVE ASSEMBLY. THERE WAS NO INJURY CAUSED BY THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000RT REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1