BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 2708772 · Received February 8, 2012

    Report

    Report Number
    3005248192-2012-00007
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 23, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    PMA / PMN Number
    K092705
    Removal / Correction Number
    FA-CAM-OCT2011-110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR HAS TAKEN A FIELD ACTION ((B)(4)) TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ON (B)(4), 2012, THROUGH AN INTERNAL AUDIT INVESTIGATION IT WAS DISCOVERED THAT THE DATE INCLUDED IN THE ORIGINAL MDR REPORT WAS INCORRECT. (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, THE ABBOTT MOLECULAR GLOBAL SERVICE AND SUPPORT ENGINEER FOUND THAT THE SENSOR HOUSING WAS DEFORMED AND THERE WAS A CRACK IN THE SENSOR OPTICAL WINDOW. THE LIQUID WASTE SENSOR WAS REPLACED ACCORDING TO INSTRUMENT SERVICE ADVISORY (ISA) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000SP JQW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1