BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEISS CIRRUS

    MDR report key: 3354824 · Received September 13, 2013

    Report

    Report Number
    MW5031841
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 7, 2013
    Report Date
    September 12, 2013
    Manufacturer
    ZEISS
    Product Code
    OBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CIRRUS MODEL 4000 SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY (OCT) UNIT THAT WE USE FOR SCREENING TESTS FOR GLAUCOMA DOES A "GUIDED PROGRESSION ANALYSIS" WHEREBY THE PT'S PRIOR TESTS ARE COMPARED TO THE CURRENT DAY'S TESTING IN ORDER TO DETECT CHANGES. ON THIS DAY, ONE PT'S GPA ANALYSIS FOR ONE EYE IMPORTED 2 PREVIOUS EXAMS FROM THE WRONG EYE OF THE WRONG PT. THIS WRONG PT HAD TESTING ON THE SAME 2 DAYS IN THE PAST AS PT KP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461012 ZEISS CIRRUS CIRRUS OBO ZEISS 4000 SD-OCT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR