BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR-3DT

    MDR report key: 2166494 · Received April 25, 2006

    Report

    Report Number
    1651093-2006-00017
    Event Type
    Malfunction
    Date Received
    April 25, 2006
    Product Code
    NFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH EXAMINATION OF THE SOFTWARE QUERIES, INOVEON CONFIRMED THE QUERY USED TO OBTAIN EVAL SUMMARY DATA REFERENCED THE ORIGINAL RECOMMENDATION DATA TABLE EVEN WHEN A REVISED RECOMMENDATION WAS AVAILABLE IN ANOTHER TABLE. AUTO PRINTING OF ISCORE REPORTS WAS SUSPENDED UNTIL A SOFTWARE MODIFICATION WAS DEVELOPED AND TESTED. AFTER SUCCESSFUL VALIDATION TESTS WERE COMPLETED, THE FIX WAS IMPLEMENTED AND AUTO PRINT FEATURE ENABLED.

    Description of Event or Problem · 1

    A RECENT DR-3DT SOFTWARE UPGRADE ENABLED AUTOMATIC ISCORE PRINTING AT FOUR LOCATIONS AROUND THE COUNTRY. THE NEW FEATURE PRODUCED SOME INACCURATE ISCORE RECOMMENDATION REPORTS. THIS MALFUNCTION WOULD LIKELY CONTRIBUTE TO SERIOUS EYE INJURY IF THE MALFUNCTION WERE TO RECUR WITHOUT BEING DETECTED. THIS ERROR ONLY OCCURRED USING THE NEW AUTOMATED ISCORE PRINTING FUNCTION. ISCORE REPORTS PRINTED BY THE AUTOMATED PRINTING PROCESS, WHERE A REVISION WAS MADE BY THE (B)(4), CONTAINED THE ORIGINAL RECOMMENDATION TEXT INSTEAD OF REVISED RECOMMENDATION. THE QUERY USED BY THE AUTOMATED ISCORE PROCESS USED THE "RECOMMENDATION" DATA FIELD FROM THE ANALYSIS TABLE INSTEAD OF THE "RECOMMENDATION" DATA FIELD FROM THE EVALSUMAUDIT TABLE IN THE DR-3DT DATABASE. NO PTS WERE INJURED. THE SOFTWARE WAS FIXED TO PRECLUDE ANY RECURRENCE OF THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DR-3DT NONE NFG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other