BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3854039 · Received June 6, 2014

    Report

    Report Number
    1225058-2014-00267
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 6, 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

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AGFA'S AWARENESS DATE IS (B)(4) 2014 FOR THIS EVENT. AGFA SUBMITTED MDR REPORT # 1225058-2010-00001 TO THE FDA FOR A CUSTOMER IN THE US. A 9TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT). WITHIN THIS 9TH OCCURRENCE ARE 7 DIFFERENT STUDY DATES FROM YEARS 2011, 2012, AND 2013, IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN). THIS IS AN INTERNAL DISCOVERY DETERMINED DURING THE IMPLEMENTATION OF THE ASSOCIATED PROBLEM CORRECTION PLAN, RMAT VERIFICATION, AS REPORTED IN (B)(4). 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: MEASUREMENT LABEL IS CHANGED ON FINDING SENTENCE "THE PRESSURE HALF TIME OF THE MITRAL VALVES IS ( ) MSEC." TO "THE PRESSURE HALF TIME OF THE MITRAL VALVES IS ( ) MMHG." (ONE LABEL INDICATES TIME, WHILE THE OTHER LABEL INDICATES PRESSURES.) THE IDENTIFICATION OF THIS SPECIFIC STUDY DATE AND MEDICAL RECORD NUMBER IS: (B)(4). AGFA INVESTIGATION INTO THE SITE'S IMPAX CV DATABASE HAS CONFIRMED THAT NO PATIENT REPORTS CURRENTLY CONTAIN THIS INCORRECT FINDING SENTENCE; THEREFORE NO PATIENTS HAVE BEEN IMPACTED BY THIS CHANGE. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. (B)(4). 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
    332367 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP. IMPAX CV 2.08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1