BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM 3

    MDR report key: 3670061 · Received January 22, 2014

    Report

    Report Number
    2952489-2014-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 22, 2014
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC.
    Product Code
    HKI
    PMA / PMN Number
    K090326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLARITY WAS ABLE TO DUPLICATE THE ISSUE USING DEVICES IN-HOUSE WITH A SIMILAR SOFTWARE CONFIGURATION; SOFTWARE VERSION 6.2. THE RETCAM OPHTHALMIC IMAGING SYSTEM CALCULATES AGE WHICH IS DISPLAYED ON THE RETCAM SYSTEM COMPUTER MONITOR IN DAYS, WEEKS, AND/OR MONTHS. THE ERROR OCCURS ONLY IN THE "WEEKS" VALUE. INTERNAL TESTS SHOW THAT IF THE PATIENT IS BORN NOVEMBER 1 TO DECEMBER 31, THE PATIENT'S DISPLAYED AGE MAY APPEAR AS MUCH AS 2 WEEKS LESS THAN THE ACTUAL AGE. FOR ALL OTHER PATIENT'S (BORN JANUARY 1 TO OCTOBER 31), THE PATIENT'S DISPLAYED AGE MAY APPEAR AS MUCH AS 1 WEEK LESS THAN THE ACTUAL AGE. THE ROOT CAUSE OF THE PROBLEM IS A SOFTWARE ANOMALY IN SOFTWARE VERSIONS 6.0, 6.1, AND 6.2. CLARITY CURRENTLY INTENDS TO ISSUE A USER SAFETY LETTER FOLLOWED BY PROVISION OF A SOFTWARE PATCH. CLARITY RISK ANALYSIS BASED UPON TYPICAL HOSPITAL WORK FLOW AND POST MARKET INFORMATION INDICATES THAT AN INJURY DUE TO THIS SOFTWARE ANOMALY IS IMPROBABLE TO REMOTE. HOSPITALS TYPICALLY USE HOSPITAL ERM SYSTEMS TO DETERMINE PATIENT AGE. THERE ARE OVER (B)(4) DEVICES IN THE FIELD WITH THIS ANOMALY. INITIAL DISTRIBUTION OF RETCAM VERSION 6 DEVICES BEGAN IN NOVEMBER 2011. THIS IS THE FIRST AND ONLY REPORT CLARITY HAS RECEIVED REGARDING THIS SOFTWARE ANOMALY.

    Description of Event or Problem · 1

    WHEN THE DOCTOR (LOCATED IN (B)(6)) WAS CREATING A NEW PATIENT RECORD IN THE RETCAM SYSTEM, SHE NOTICED THAT THE CALCULATED AGE OF THE PATIENT APPEARED WRONG. PATIENT WAS NOT INJURED. PATIENT AGE IS CALCULATED AT THE TIME OF RETCAM USE BASED ON PATIENT'S DATE OF BIRTH. PATIENT AGE IS PROVIDED FOR REFERENCE INFORMATION ONLY. PHYSICIANS DO NOT TYPICALLY RELY ON RETCAM CALCULATED AGE TO DETERMINE START OF SCREENING AND/OR FOLLOW UP EXAMINATIONS FOR MONITORING RETINOPATHY OF PREMATURITY (ROP). IN THIS CASE, THE DOCTOR WAS NOT USING THE RETCAM DISPLAYED AGE TO DETERMINE THE DATE FOR INITIAL OR FOLLOW UP ROP SCREENING. HOWEVER, IN THE VERY UNLIKELY SCENARIO THAT A MEDICAL PROFESSIONAL RELIES ON THE AGE OF THE PATIENT AS DISPLAYED ON THE RETCAM SYSTEM FOR INITIATION OF SCREENING, HE MIGHT START ROP SCREENING LATER THAN RECOMMENDED (UP TO 2 WEEKS IN THE WORST CASE). FAILURE TO TIMELY SCREEN AND PROACTIVELY TREAT (IF DEEMED MEDICALLY NECESSARY) MIGHT RESULT IN PERMANENT IMPAIRMENT OF VISION. NOTE THAT THERE HAVE BEEN NO PREVIOUS REPORTS OF THIS ISSUE TO DATE. THIS SOFTWARE IS INSTALLED ON OVER (B)(4) DEVICES/BEEN IN FIELD FOR 2 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51595 RETCAM 3 OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS, INC. RETCAM 3

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA