BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAX CV REPORTING

    MDR report key: 2500843 · Received March 20, 2012

    Report

    Report Number
    1225058-2012-00004
    Event Type
    Other
    Date Received
    March 20, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 20, 2012
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K022292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SOFTWARE VERSIONS FOR IMPAX CV REPORTING WITH STYLESHEET CUSTOMIZATION ARE FROM: VERSION 2.03 B18 RELEASED FEBRUARY 6, 2004 TO VERSION 7.8 SU2 RELEASED SEPTEMBER 15, 2010. THE CUSTOMER SPECIFIC SOFTWARE VERSION IS 2.08.12 SU4, WHICH IS INCLUDED IN VERSION 7.4.SU3 RELEASED OCTOBER 9, 2009. EVALUATION SUMMARY: EVEN THOUGH THE CUSTOMER APPROVED THE CUSTOMIZATION CHANGES AND SIGNED OFF ON THE CHANGES WITHIN THEIR TEST ENVIRONMENT, AGFA DETERMINED THAT THE CONTENT/STYLESHEET CUSTOMIZATION CHANGES MADE IN THE TEST SYSTEM WERE NOT FULLY TESTED BEFORE MOVING TO THE CUSTOMER'S PRODUCTION ENVIRONMENT. THE USER ASSUMED THAT THE CONTENT IN THE "REPORT WRITER" FREE TEXT FIELDS AND THE XML STYLE SHEETS WERE THE SAME AND THEREFORE DID NOT REVIEW THE PRINTED REPRESENTATION OF THE REPORT PRIOR TO SIGNING THE FINAL VERSION AND IMPLEMENTING ON THEIR PRODUCTION SYSTEM. AGFA MADE THE APPROPRIATE NUCLEAR MEDICINE STYLESHEET CORRECTIONS AND ELIMINATED THE ERRORS. AGFA'S TECHNICAL PRODUCT MANAGER SET THE NUCLEAR CARDIOLOGY XML STYLE SHEET FORMAT BACK TO THE PRIOR SETTING BEFORE (B)(6) 2012. ON (B)(6) 2012, THE SITE SIGNED OFF ON THIS VERSION OF THE NUCLEAR CARDIOLOGY REPORT FORMAT. AGFA WORKED WITH THE SITE TO IDENTIFY ALL AFFECTED REPORTS SINCE THE IMPLEMENTATION OF THE CUSTOMIZATION AND TO ENSURE NO PT HARM WAS CAUSED BY THE ISSUE. THE 106 REPORTS WERE REVIEWED AND 102 REPORTS WERE NOT AFFECTED. BOTH AGFA AND THE SITE'S PHYSICIANS IDENTIFIED THE SAME 4 (FOUR) REPORTS THAT MERITED FURTHER EVALUATION FOR PT IMPACT. TWO READING PHYSICIANS AMENDED THE REPORTS WITH THE MISSING INFORMATION OF THE FOUR IDENTIFIED REPORTS AND RE-SIGNED THE REPORTS. THESE PHYSICIANS EVALUATED POTENTIAL RISKS AND IF THESE 4 REPORTS WARRANTED INFORMING THE REFERRING PHYSICIANS. THE READING PHYSICIANS CONFIRMED THERE WAS NO NEGATIVE IMPACT ON PT CARE AND THAT ALL RELEVANT FINDINGS WERE CONTAINED WITHIN THE FOUR RE-SIGNED REPORTS. DURING THE ENTIRE EVENT, THERE WERE NO REPORTS OF PT HARM.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER REQUESTED AGFA TO PERFORM AN XML STYLE SHEET CHANGE FOR THE PRINTED NUCLEAR CARDIOLOGY REPORT. (NOTE: PER AGFA POLICY, STYLESHEET CUSTOMIZED MUST BE CUSTOMIZED BY AGFA.) AGFA CUSTOMIZED THE TEXT ENTERED INTO THE REPORT WRITER SCREEN "COMMENTS" AND "CONCLUSIONS", AND THE FREE TEXT FIELDS WERE MERGED FOR PRESENTATION WITHIN THE XML STYLE SHEET UNDER A COMBINED "CONCLUSIONS" HEADING MOVED TO THE TOP OF THE SIGNED REPORT. AGFA ADDED THE CUSTOMIZED XML STYLE SHEET TO THE SITE'S TEST SYSTEM. TEST REPORTS WERE THEN CREATED BY BOTH AGFA AND THE HOSPITAL CLINICAL PERSONNEL. CUSTOMER APPROVAL OF THE CHANGES AND SIGN OFF WERE OBTAINED ON (B)(6) 2012. THE CHANGES WERE INTRODUCED INTO THE HOSPITAL'S PRODUCTION SYSTEM ON (B)(6) 2012. ON (B)(6) 2012, THE SITE'S PHYSICIAN FIRST NOTICED THAT THE CONTENT ENTERED INTO THE "CONCLUSIONS" FREE TEXT BOX ON THE REPORT WRITER SCREEN WAS NOT REPRESENTED ON THE FINAL PRINTED REPORT. THE SAME DAY, THE SITE DETERMINED AN INTERIM SOLUTION FOR THIS ISSUE BY ENTERING SOME DATA OR A CHARACTER INTO THE "NOTES" SECTION LOCATED WITHIN THE "NUCLEAR CARDIOLOGY CONCLUSIONS" SCREEN. THE CONTENT COULD THEN BE DISPLAYED FOR THE PHYSICIAN. THE PHYSICIAN CONFIRMED THE DELAY OF THE PROPER FINAL REPORT DID NOT HARM OR COMPROMISE THE CARE OF THAT PT. ON (B)(6) 2012, THE SITE REPORTED THEIR DISCOVERY TO AGFA. AGFA'S ANALYSIS QUICKLY DETERMINED THAT THE CONTENT/STYLESHEET CUSTOMIZATION CHANGES MADE IN THE TEST SYSTEM WERE NOT FULLY TESTED BEFORE MOVING TO THE CUSTOMER'S PRODUCTION ENVIRONMENT. THE USER ASSUMED THAT THE CONTENT IN THE "REPORT WRITER" FREE TEXT FIELDS AND THE XML STYLE SHEETS WERE THE SAME AND THEREFORE DID NOT REVIEW THE PRINTED REPRESENTATION OF THE REPORT PRIOR TO SIGNING THE FINAL VERSION AND IMPLEMENTING ON THEIR PRODUCTION SYSTEM. AGFA IMMEDIATELY MADE THE APPROPRIATE NUCLEAR MEDICINE STYLESHEET CORRECTIONS AND ELIMINATED THE ERRORS. AGFA'S TECHNICAL PRODUCT MANAGER SET THE NUCLEAR CARDIOLOGY XML STYLE SHEET FORMAT BACK TO THE PRIOR SETTING BEFORE (B)(6) 2012, THE SITE SIGNED OFF ON THIS VERSION OF THE NUCLEAR CARDIOLOGY REPORT FORMAT. AGFA WORKED WITH THE SITE TO IDENTIFY ALL AFFECTED REPORTS SINCE THE IMPLEMENTATION OF THE CUSTOMIZATION AND TO ENSURE NO PT HARM WAS CAUSED BY THE ISSUE. THE 106 REPORTS WERE REVIEWED AND 102 REPORTS WERE NOT AFFECTED. BOTH AGFA AND THE SITE'S PHYSICIANS IDENTIFIED THE SAME 4 (FOUR) REPORTS THAT MERITED FURTHER EVALUATION FOR PT IMPACT. TWO READING PHYSICIANS AMENDED THE REPORTS WITH THE MISSING INFORMATION OF THE FOUR IDENTIFIED REPORTS AND RE-SIGNED THE REPORTS. THESE PHYSICIANS EVALUATED POTENTIAL PT RISKS AND IF THESE 4 REPORTS WARRANTED INFORMING THE REFERRING PHYSICIANS. THE READING PHYSICIANS CONFIRMED THERE WAS NO NEGATIVE IMPACT ON PT CARE AND THAT ALL RELEVANT FINDINGS WERE CONTAINED WITHIN THE FOUR RE-SIGNED REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV REPORTING PICTURE ARCHIVING AND COMMUNICATIONS LLZ AGFA HEALTHCARE CORP. SW VERSIONS SEE H10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1