DR-3DT

Additional Manufacturer Narrative

THE INACCURATE ISCORE RECOMMENDATION REPORTS WERE PRODUCED USING A NEW AUTOMATED ISCORE PRINTING FUNCTION RELEASED AS SOFTWARE VERSION 1.5. THE ISCORE REPORTS GENERATED BY THIS NEW AUTOMATION FEATURE, WHERE A REVISION TO THE ORIGINAL RECOMMENDATION WAS MADE BY THE TRIAGE MANAGER, PRINTED THE ORIGINAL RECOMMENDATION WAS MADE BY THE TRIAGE MANAGER, PRINTED THE ORIGINAL RECOMMENDATION INSTEAD OF THE TRIAGE MANAGER'S REVISED RECOMMENDATION. THE QUERY USED BY THE AUTOMATED ISCORE SOFTWARE PROCESS ACCESSED THE "RECOMMENDATION" DATA FIELD FROM THE ANALYSIS TABLE INSTEAD OF THE "RECOMMENDATION" DATA FIELD FROM THE EVALSUMAUDIT TABLE IN THE DR-3DT DATABASE. THROUGH EXAMINATION OF THE SOFTWARE QUERIES, INOVEON CONFIRMED THE QUERY USED TO OBTAIN EVALUATION SUMMARY DATA REFRENCED 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 SOFTWARE FIX WAS IMPLEMENTED AND AUTO PRINT FEATURE ENABLED.

Description of Event or Problem

A RECENT DR-3DT SOFTWARE RELEASE PRODUCED INACCURATE ISCORE RECOMMENDATION REPORTS AT FOUR LOCATIONS AROUND THE COUNTRY. THE SOFTWARE RESIDES ON A CENTRAL SERVER ACCESSED FROM THE FOUR SITES. THE INACCURATE RECOMMENDATION REPORTS WOULD LIKELY CONTRIBUTE TO SERIOUS EYE INJURY IF THE MALFUNCTION WERE TO RECUR WITHOUT BEING DETECTED. FORTY-FIVE PATIENTS (SEE CONTINUATION PAGE FOR LISTING) COULD HAVE BEEN AFFECTED BY THE INACCURATE ISCORE REPORTS. HUMAN INTERVENTION PREVENTED THIS OCCURRENCE. THE SOFTWARE WAS FIXED TO PRECLUDE ANY RECURRENCE OF THIS ERROR. NO PATIENTS WERE INJURED.