BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MICROLAB AT PLUS2

    MDR report key: 279403 · Received May 22, 2000

    Report

    Report Number
    2915796-2000-00010
    Event Type
    Malfunction
    Date Received
    May 22, 2000
    Date of Event
    April 19, 2000
    Report Date
    May 19, 2000
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAMILTON CO WAS NOTIFIED OF AN EVENT IN WHICH A MICROLAB AT + 2 INSTRUMENT ASPIRATED INCORRECT SAMPLE VOLUME. THE TECHNICIAN STOPPED THE RUN AND RESET THE INSTRUMENT. NO DEATH OR INJURY IS ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT CORRESPONDS TO HAMILTON CUSTOMER PROBLEM REPORT NUMBER 4979.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MICROLAB AT PLUS2 MICROTITER DILUTING/DISPENSING JTC HAMILTON BONADUZ AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other