BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPCON

    MDR report key: 6239180 · Received January 10, 2017

    Report

    Report Number
    1000307022-2017-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 10, 2017
    Manufacturer
    TOPCON MEDICAL SYSTEMS, INC.
    Product Code
    NFJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STATUS UPDATE: INVESTIGATION (TOPCON) TOPCON PROVIDED AN UPDATED STATUS REGARDING THE ONGOING INVESTIGATION INTO THE MISPLACED PATIENT EXAM DATA RECORD. THE FINAL LIST OF EXAM RECORDS IMPACTED WAS 6. ALL OF THE IMPACTED RECORDS HAVE BEEN STALED (HIDDEN) WITHIN SYNERGY SO THAT THERE IS NO CHANCE OF CONFUSION MOVING FORWARD. THE LIST OF IMPACTED PATIENTS WAS PROVIDED TO OPP. THE ROOT CAUSE OF THE ISSUE (A SETTING THAT HAD BEEN CHANGED IN THE LENSTAR) HAS BEEN CORRECTED (THE SETTING WAS CHANGED BACK TO ITS ORIGINAL VALUE) AND THERE IS NO FURTHER RISK OF MISFILED PATIENT RECORDS. OPP HAS BEEN INSTRUCTED TO COMMUNICATE AND DEVICE CONFIGURATION CHANGES TO THE TOPCON TECHNICAL SUPPORT TEAM SO THAT THEY CAN VERIFY THE CORRECT FUNCTIONING OF THE DATA HARVEST PROCESS INTO SYNERGY.

    Description of Event or Problem · 1

    A PATIENT'S DIAGNOSTIC REPORT WITH NAME AND DEMOGRAPHICS DETAIL ENDED UP IN ANOTHER PATIENT'S CHART. WHEN THE CHART WAS PULLED FOR CATARACT SURGERY LENS CALCULATIONS, THE WRONG REPORT APPEARED. THE REPORT NAME AND DEMOGRAPHICS WERE NOT NOTICED AND THE WRONG CALCULATIONS WERE MADE TO CHOSE AN INTEROCULAR LENS FOR SURGERY. THE ISSUE WAS NOTICED WHEN THE DOCTOR WAS TRYING TO FIGURE OUT WHY THE POST-OPERATIVE RESULTS WERE SO UNEXPECTED. THIS COULD HAVE REQUIRE A SECOND (UNNECESSARY) OPERATION FOR THIS PATIENT TO EXCHANGE THE INTRAOCULAR LENS FOR THE CORRECT ONE, BUT DID NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22949 TOPCON SYNERGY NFJ TOPCON MEDICAL SYSTEMS, INC. VERSION 3.03

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other LENSTAR