BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2000SP

    MDR report key: 1161496 · Received September 15, 2008

    Report

    Report Number
    3005248192-2008-00002
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    PMA / PMN Number
    BP060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR HAS IDENTIFIED A REPLACEMENT TAPE TO SECURE THE FRONT HOOD PANEL. A CUSTOMER LETTER HAS BEEN ISSUED INFORMING THE CUSTOMERS THAT HAVE A HOOD ON THEIR M2000SP SYSTEM THAT A SERVICE CALL WILL BE SCHEDULED. IF THE CUSTOMER SUSPECTS THAT THE FRONT HOOD PANEL IS LOOSE, THEN THE M2000SP INSTRUMENT IS NOT TO BE USED UNTIL THE SERVICE VISIT IS COMPLETE. ADDITIONAL MODEL #: 9K14-02.

    Description of Event or Problem · 1

    THE FRONT HOOD PANEL OF THE M2000SP INSTRUMENT HAS ADHESIVE ON THE DOUBLE-COATED TAPE THAT WAS NOT STRONG ENOUGH TO HOLD THE WINDOW IN PLACE. FIVE INTERNAL INSTANCES HAVE BEEN DOCUMENTED. ADDITIONALLY, FIVE CUSTOMER OBSERVATIONS OF THE HOOD FRONT WINDOW FALLING OFF HAVE BEEN DOCUMENTED. NONE OF THESE INDIVIDUAL INSTANCES HAVE RESULTED IN A MEDICAL DEVICE REPORT (FORM 3500A). HOWEVER, ABBOTT MOLECULAR (AM) TOOK A FIELD ACTION IN 2008. THUS ABBOTT MOLECULAR IS FILING THIS MDR DUE TO THIS SITUATION'S MALFUNCTION AND ABBOTT MOLECULAR'S FIELD CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2000SP AUTOMATED SAMPLE PREPARATION SYSTEM KEY ABBOTT MOLECULAR, INC. 9K014-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other