FDA Adverse Event Malfunction Summary report: N

CARESTREAM HEALTH

MDR report key: 1993905 · Received February 11, 2011

Report

Report Number
MW5019410
Event Type
Malfunction
Date Received
February 11, 2011
Report Date
February 11, 2011
Manufacturer
CARESTREAM HEALTH
Product Code
LLZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
RADIOLOGIC TECHNOLOGIST

Narratives

Description of Event or Problem · 1

DURING THE (B)(6) OF 2009, OUR RADIOLOGY PRACTICE SHIFTED FROM FILM-BASED MAMMOGRAPHY TO DIGITAL MAMMOGRAPHY. WITH DIGITAL MAMMOGRAPHY, OUR RADIOLOGISTS BEGAN PERFORMING ONLINE DIAGNOSIS USING CARESTREAM RIS-DIC SYSTEM. WHEN USING THE SYSTEM, THE RADIOLOGIST WILL CHOOSE A DROP DOWN MENU TO SELECT A BREAST DENSITY TYPE AND A BIRADS CATEGORY (OVERALL DIAGNOSIS). USING THE MOUSE, THE RADIOLOGIST MAY SELECT A PARTICULAR BREAST DENSITY OR A BIRADS CATEGORY ON AN ADMINISTRATIVE MONITOR, TO SHIFT THE MOUSE TO FOCUS TO THE (B)(6)-MONITORS TO SCROLL THROUGH DIGITAL IMAGES. IN SO DOING, THE SELECTIONS PREVIOUSLY MADE ON THE ADMINISTRATIVE MONITOR FOR BREAST DENSITY AND BIRADS CATEGORY CHANGE AS THE RADIOLOGIST SCROLLS THROUGH IMAGES, EVEN THOUGH THE MOUSE IS POINTED TO A (B)(6) MONITOR. THE BIRADS CATEGORY ULTIMATELY SELECTED HAS SEVERAL CONSEQUENCES. IT IS IMPORTED AS A FINAL RESULT IN MAMMOGRAPHY REPORTS. IT IS USED TO DETERMINE THE CONTENT OF THE LAY LETTER TO THE PTS, INFORMING THEM THAT THE RESULT WAS NORMAL OR THAT ADDITIONAL IMAGING IS NEEDED. IT IS ALSO TO ESTABLISH THE INTERVAL FOR THE PTS NEXT APPOINTMENT, RANGING FROM THE IMMEDIATE NEED TO RETURN FOR ADDITIONAL IMAGING TO SIX MONTHS FOR A SHORT F/U OR TWELVE MONTHS FOR AN ANNUAL REMINDER. WHEN (B)(6) FIRST BECAME AWARE OF THE DEFICIENCIES IN (B)(6) 2009, WE NOTIFIED CARESTREAM PERSONNEL THROUGH A SERIES OF EMAILS THAT "USE OF A DROP DOWN MENU IS UNACCEPTABLE FOR MEDICAL DIAGNOSIS AND IT NEEDED TO BE MODIFIED. A SOLUTION WAS PROPOSED TO SWITCH THE DROP DOWN MENU TO DISCRETE RADIO BUTTONS. (B)(6) PERSONNEL HAVE FOLLOWED UP WITH CARESTREAM ON THIS ISSUE NUMEROUS TIMES. WE HAVE BEEN UNABLE TO GET CARESTREAM HEALTH TO DEAL WITH THIS ISSUE SERIOUSLY AND TO DEVELOP A SOLUTION. DATES OF USE: (B)(6) 2005 -- (B)(6) 2011.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARESTREAM HEALTH RIS-DIC, PACS SYSTEM - RADIOLOGY INFORMATION AND DICTATION SYSTEM LLZ CARESTREAM HEALTH VERSION 10.1.6

Patients

Seq Age Sex Outcome Treatment
1