BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 2698859 · Received January 9, 2012

    Report

    Report Number
    3005248192-2012-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 14, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. DURING INSPECTION OF THE M2000SP LIQUID WASTE SENSOR, ABBOTT SUPPORT PERSONNEL FOUND THAT THE SENSOR HOUSING WAS DEFORMED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000SP STATION PIPETTING AND DILUTING FOR CLINICAL USE JQW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1