BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSINI

    MDR report key: 4322193 · Received December 1, 2014

    Report

    Report Number
    3008251789-2014-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 17, 2014
    Manufacturer
    I-OPTICS BV
    Product Code
    MMQ
    PMA / PMN Number
    EXEMPTED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AFTER UPGRADING THE CASSINI SOFTWARE AT A CUSTOMER BY AN I-OPTICS' REPRESENTATIVE, A NEW PATIENT WAS SCANNED. THE I-OPTICS EMPLOYEE DISCOVERED THAT THIS PATIENT EXAMINATION DATA WAS LINKED TO ANOTHER (PREVIOUSLY) SCANNED PATIENT. ALL OTHER PATIENT RECORDS WERE CHECKED BY THE CUSTOMER AND I-OPTICS EMPLOYEE TO CONFIRM NO CHARTS WOULD BE AFFECTED. NO PT DATA WAS USED FOR DIAGNOSIS OR THERAPEUTIC TREATMENT BETWEEN THE UPDATE AND RECORD INTEGRITY CHECK. NO PTS WERE AFFECTED. THE ISSUE WAS IMMEDIATELY REPORTED TO I-OPTICS BV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775498 CASSINI CORNEAL TOPOGRAPHER SYSTEM MMQ I-OPTICS BV SOFTWARE V2.0.0

    Patients

    Seq Age Sex Outcome Treatment
    1