BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV REPORTING

    MDR report key: 3912587 · Received May 14, 2014

    Report

    Report Number
    1225058-2014-00260
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    May 12, 2011
    Report Date
    May 14, 2014
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGFA INVESTIGATION DISCOVERED THE ROOT CAUSE TO BE DUE TO IMPAX CV OUTBOUND MISCONFIGURATION IN COMBINATION WITH NEARLY SIMULTANEOUS PHYSICIAN SIGNING OF THE FINAL PATIENT REPORT. IMPAX CV OUTBOUND SERVICE WAS MISCONFIGURED TO INCLUDE A SECONDARY PDF FOLDER LOCATION. THE REPORT MISATTRIBUTION WOULD OCCUR WHEN SEPARATE PHYSICIANS WOULD SIGN SEPARATE PATIENT REPORTS NEARLY SIMULTANEOUSLY (WITHIN MILLISECONDS OF EACH OTHER) OR IF A SINGLE PHYSICIAN SIGNED SEPARATE PATIENT REPORTS NEARLY SIMULTANEOUSLY WITH THE USE OF THE "BATCH" SIGNING OPTION. MEDICAL RECORD NUMBERS (MRNS) FOR THIS REPORT WERE IDENTIFIED AND MISATTRIBUTION OCCURRED AND BATCHED ON THE SAME DAY: (B)(6). THERE HAVE BEEN NO OTHER REPORTS OF THIS ISSUE OCCURRING AT OTHER SITES AND THE CONFIGURATION HAS ALREADY BEEN CORRECTED AT THIS SITE SUCCESSFULLY. THE SITE HAS SINCE UPGRADED FROM IMPAX CV 7.2 TO IMPAX CV 7.8 SU3. AGFA'S OUTBOUND AUTO PRINT CONFIGURATION GUIDE WAS UPDATED AND APPROVED (B)(4) 2012 TO PROVIDE CONFIGURATION INSTRUCTIONS AND IS INTENDED TO BE USED BY AGFA GLOBAL PROFESSIONAL SERVICES PERFORMING ADVANCED CONFIGURATION OF IMPAX CV.

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORTS# 1225058-2012-00007, 1225058-2012-00008 AND 1225058-2012- 00009 FOR THE SAME SITE IN THIS NEW REPORT DATED (B)(4) 2014. AGFA PERFORMED AND COMPLETED A RETROSPECTIVE REVIEW FOR THE EVENTS THAT OCCURRED AT THIS SITE AND IDENTIFIED ADDITIONAL PAST OCCURRENCES THAT ARE BEING REPORTED TO THE FDA. THE ISSUE WAS PATIENT STUDY REPORT/S WAS INTERMITTENTLY EXPORTED TO THE WRONG PATIENT WITHIN HIS. REPORT/S WERE CREATED IN IMPAX CV REPORTING AND CONVERTED INTO (B)(4) PDF VERSIONS, (VIA A 3RD PARTY TOOL CALLED (B)(4)) FOR PRESENTATION IN IMPAX CV REPORTING AND THE HOSPITAL'S INFORMATION SYSTEM (HIS). AFTER THE EXPORT OF THE REPORT/S TO THE HIS, THE REPORT OF PATIENT A (DEMOGRAPHICS AND FINDINGS OF PATIENT A) WAS SOMETIMES ASSIGNED TO A DIFFERENT PATIENT B. THERE HAS BEEN NO PATIENT HARM DUE TO THESE OCCURRENCES.

    Additional Manufacturer Narrative · 2

    AGFA INVESTIGATION DISCOVERED THE ROOT CAUSE TO BE DUE TO IMPAX CV OUTBOUND MISCONFIGURATION IN COMBINATION WITH NEARLY SIMULTANEOUS PHYSICIAN SIGNING OF THE FINAL PATIENT REPORT. IMPAX CV OUTBOUND SERVICE WAS MISCONFIGURED TO INCLUDE A SECONDARY PDF FOLDER LOCATION. THE REPORT MISATTRIBUTION WOULD OCCUR WHEN SEPARATE PHYSICIANS WOULD SIGN SEPARATE PATIENT REPORTS NEARLY SIMULTANEOUSLY (WITHIN MILLISECONDS OF EACH OTHER) OR IF A SINGLE PHYSICIAN SIGNED SEPARATE PATIENT REPORTS NEARLY SIMULTANEOUSLY WITH THE USE OF THE "BATCH" SIGNING OPTION. MEDICAL RECORD NUMBERS (MRNS) FOR THIS REPORT WERE IDENTIFIED AND MISATTRIBUTION OCCURRED AND BATCHED ON THE SAME DAY: (B)(6). THERE HAVE BEEN NO OTHER REPORTS OF THIS ISSUE OCCURRING AT OTHER SITES AND THE CONFIGURATION HAS ALREADY BEEN CORRECTED AT THIS SITE SUCCESSFULLY. THE SITE HAS SINCE UPGRADED FROM IMPAX CV 7.2 TO IMPAX CV 7.8 SU3. AGFA'S OUTBOUND AUTO PRINT CONFIGURATION GUIDE WAS UPDATED AND APPROVED (B)(4) 2012 TO PROVIDE CONFIGURATION INSTRUCTIONS AND IS INTENDED TO BE USED BY AGFA GLOBAL PROFESSIONAL SERVICES PERFORMING ADVANCED CONFIGURATION OF IMPAX CV.

    Description of Event or Problem · 2

    AGFA SUBMITTED MDR REPORTS# 1225058-2012-00007, 1225058-2012-00008 AND 1225058-2012- 00009 FOR THE SAME SITE IN THIS NEW REPORT DATED (B)(4) 2014. AGFA PERFORMED AND COMPLETED A RETROSPECTIVE REVIEW FOR THE EVENTS THAT OCCURRED AT THIS SITE AND IDENTIFIED ADDITIONAL PAST OCCURRENCES THAT ARE BEING REPORTED TO THE FDA. THE ISSUE WAS PATIENT STUDY REPORT/S WAS INTERMITTENTLY EXPORTED TO THE WRONG PATIENT WITHIN HIS. REPORT/S WERE CREATED IN IMPAX CV REPORTING AND CONVERTED INTO (B)(4) PDF VERSIONS, (VIA A 3RD PARTY TOOL CALLED (B)(4)) FOR PRESENTATION IN IMPAX CV REPORTING AND THE HOSPITAL'S INFORMATION SYSTEM (HIS). AFTER THE EXPORT OF THE REPORT/S TO THE HIS, THE REPORT OF PATIENT A (DEMOGRAPHICS AND FINDINGS OF PATIENT A) WAS SOMETIMES ASSIGNED TO A DIFFERENT PATIENT B. THERE HAS BEEN NO PATIENT HARM DUE TO THESE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288256 IMPAX CV REPORTING SYSTEM, IMAGE PROCESSING, RADIOLOGIC LLZ AGFA HEALTHCARE CORP. CV SUITE 7.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2