BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3957892 · Received June 17, 2014

    Report

    Report Number
    1225058-2014-00279
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGFA SUBMITTED MDR REPORT #1225058-2010-00001 TO THE FDA ON (B)(4) 2010 FOR A SITE IN THE US. A 10TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT). THIS IS AN INTERNAL DISCOVERY DETERMINED DURING THE IMPLEMENTATION OF THE ASSOCIATED PROBLEM CORRECTION PLAN, RMAT VERIFICATION, AS REPORTED IN FDA Z-2112-10. WITHIN THIS 10TH OCCURRENCE ARE 55 DIFFERENT STUDY DATES FROM YEARS 2005 TO 2014, IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN). AN AGFA CLINICAL ANALYST PERFORMED A RETRO-ANALYSIS AND REPORTED THE FINDINGS TO AGFA SERVICE NAD AGFA PRODUCT QUALITY MANAGER. AGFA'S INVESTIGATION INTO THIS OCCURRENCE OF RMAT CUSTOMIZATIONS HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: FINDING SENTENCE FOR FINDING ID = (B)(4) HAS BEEN CHANGED FROM "THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION." TO "THE AORTIC VALVE LEAFLETS ARE THICKENED WITH REDUCED SYSTOLIC EXCURSION." HISTORICALLY, THIS WILL CHANGE ANY AMENDED REPORT THAT PREVIOUSLY INCLUDED THE PHRASE "SEVERELY THICKENED." NO PATIENT HARM HAS BEEN REPORTED. CURRENTLY 59 AMENDED REPORTS INCLUDE THIS STATEMENT. THERE ARE 55 UNIQUE STUDY DATES WITHIN THE 59 REPORTS. A MDR WILL BE REPORTED FOR EACH OF THE STUDY DATES. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # IS Z-2112-10. AGFA WILL FOLLOW THE RMAT POST MARKET VERIFICATION WORK INSTRUCTIONS TO CORRECT THE SENTENCE FINDING. ANY FURTHER INVESTIGATION FOR THE SITE DESCRIBED IN THIS REPORT WILL BE DOCUMENTED IN THE ONGOING CFR PART 806 REPORTING. FIFTY FIVE SEPARATE MDRS WILL BE REPORTED. THE MDR NUMBERS AND IDENTIFICATION OF THE SPECIFIC STUDY DATES AND MEDICAL RECORD NUMBERS ARE: (B)(4).

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT #1225058-2010-00001 TO THE FDA ON (B)(4) 2010 FOR A SITE IN THE US. A 10TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT). THIS IS AN INTERNAL DISCOVERY DETERMINED DURING THE IMPLEMENTATION OF THE ASSOCIATED PROBLEM CORRECTION PLAN, RMAT VERIFICATION, AS REPORTED IN FDA Z-2112-10. AN AGFA CLINICAL ANALYST PERFORMED A RETRO-ANALYSIS AND REPORTED THE FINDINGS TO AGFA'S INVESTIGATION INTO THIS OCCURRENCE OF RMAT CUSTOMIZATIONS HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: FINDING SENTENCE FOR FINDING ID = (B)(4) HAS BEEN CHANGED FROM "THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION." TO "THE AORTIC VALVE LEAFLETS ARE THICKENED WITH REDUCED SYSTOLIC EXCURSION." HISTORICALLY, THIS WILL CHANGE ANY AMENDED REPORT THAT PREVIOUSLY INCLUDED THE PHRASE "SEVERELY THICKENED." NO PATIENT HARM HAS BEEN REPORTED. CURRENTLY 59 AMENDED REPORTS INCLUDE THIS STATEMENT. THERE ARE 55 UNIQUE STUDY DATES WITHIN THE 59 REPORTS. A MDR WILL BE REPORTED FOR EACH OF THE STUDY DATES. THE MEDICAL RECORD NUMBER AND STUDY DATE FOR THIS MDR IS: MRN # (B)(4). STUDY DATE: (B)(4) 2005. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # IS Z-2112-10. AGFA WILL FOLLOW THE RMAT POST MARKET VERIFICATION WORK INSTRUCTIONS TO CORRECT THE SENTENCE FINDING. ANY FURTHER INVESTIGATION FOR THE SITE DESCRIBED IN THIS REPORT WILL BE DOCUMENTED IN THE ONGOING CFR PART 806 REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354491 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP. IMPAX CV RM 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1