BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3994824 · Received June 17, 2014

    Report

    Report Number
    1225058-2014-00277
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN AGFA CLINICAL ANALYST PERFORMED A RETRO-ANALYSIS AND REPORTED THE FINDINGS TO AGFA SERVICE AND 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: THE FINDING GROUP FOR AORTIC VALVE/STRUCTURE/THICKENING WAS CONVERTED FROM CHECK BOXES TO RADIO BUTTONS. THE RISK HERE IS THAT THE CUSTOMER IS UNABLE TO DOCUMENT ALL THE INFORMATION FOR EACH VALVE LEAFLET THICKENING LOCATION AND MAY NOT REALIZE THIS FACT. CURRENTLY (B)(4) DIFFERENT STUDY DATE REPORTS SHOW EVIDENCE OF THIS FINDING. THESE (B)(4) REPORTS COULD POSSIBLY BE ACCEPTABLE, BUT THERE IS ALSO A RISK THAT THEY HAVE SOME MISSING INFORMATION BASED ON THIS CHANGE. IT IS UNKNOWN AT THIS TIME IF THE CHANGE IS BY THE CUSTOMER'S PREFERENCE. AGFA IS CURRENTLY INVESTIGATING WITH THE CUSTOMER TO DETERMINE IF THE REPORTS ARE MISCONFIGURED. (B)(4). 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.

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT # 1225058-2010-00001 TO THE FDA 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356799 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