BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 474578 · Received July 24, 2003

    Report

    Report Number
    2250051-2003-00938
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    July 15, 2003
    Report Date
    July 23, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    GKH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PROCESSING PLATES ON THE OSP USING SYRINGE THE TECH OBSERVED THAT THE SYRINGES WERE BENT IN SUCH A WAY THAT CAUSED THEM TO IMPROPERLY DISPENSE FLUID INTO THE MICROWELL. NO ERROR WAS GENERATED BY THE OSP. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 31200392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR SAMPLE PROCESSOR GKH ORTHO-CLINICAL DIAGNOSTICS 7003015 30203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other