BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 474587 · Received July 24, 2003

    Report

    Report Number
    2250051-2003-00933
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    July 11, 2003
    Report Date
    July 23, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    GKH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PROCESSING PLATES ON THE OSP USING SYRINGE THE TECHNICIAN OBSERVED THAT THE SYRINGES WERE BENT IN SUCH A WAY THAT MAY CAUSE THEM TO IMPROPERLY DISPENSE FLUID INTO THE MICROWELL. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 31200073.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR SAMPLE PROCESSOR GKH ORTHO-CLINICAL DIAGNOSTICS 7003015 31003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other