BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 5152196 · Received February 11, 2004

    Report

    Report Number
    2250051-2004-00056
    Event Type
    Malfunction
    Date Received
    February 11, 2004
    Date of Event
    January 17, 2004
    Report Date
    February 10, 2004
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO SAMPLE/NO ERROR MESSAGE WAS NOT GENERATED BY THE SUMMIT. LOW SAMPLE/DILUENT IN WELL H12 DURING PIPETTING. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR GJG HAMILTON BONADUZ AG 7003009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other