BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4293418 · Received November 24, 2014

    Report

    Report Number
    1225058-2014-06289
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 24, 2014
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Product Code
    LLX
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AGFA CLINICAL ANALYST PERFORMED A RETRO-ANALYSIS AND REPORTED THE FINDINGS TO AGFA SERVICE AN AGFA PRODUCT QUALITY MANAGER. AGFA'S INVESTIGATION INTO THIS OCCURRENCE OR RMAT CUSTOMIZATIONS HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: NO VEGETATION IS OBSERVED ON THE MITRAL VALVE: HAS BEEN CHANGED TO:" THERE ARE ECHO FINDINGS CONSISTENT WITH A MASS INVOLVING THE ANTERIOR LEAFLET OF THE MITRAL VALVE". THE ORIGINAL SENTENCE DESCRIBES THE ABSENCE OF VEGETATION ON THE MITRAL VALVE. THIS HAS BEEN CHANGED TO CONTAIN CONTRADICTORY CLINICAL FINDINGS WHICH INDICATE THE PRESENCE OF A MASS ON THE ANTERIOR MITRAL VALVE LEAFLET. THIS IS CLINICALLY INACCURATE AND NOT WHAT THE READING CARDIOLOGIST INTENDED. POTENTIAL IMPACT: IF THE CHANGE WAS MADE AFTER REPORTS HAD BEEN GENERATED WITH THE ORIGINAL SENTENCE SELECTED, THOSE REPORTS PRIOR TO THE CHANGE COULD DISPLAY INCORRECT CLINICAL DATA IF VIEWED IN RM OR IF USED AS A TEMPLATE FOR A REPEAT STUDY ON THAT PATIENT. AS SOON AS AGFA IS MADE AWARE OF ANY AFFECTED REPORTS RELATED TO THIS SPECIFIC FINDING, FOLLOW-UP MDRS WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND RESPECTIVE MEDICAL RECORD NUMBER/S (MRN) IDENTIFIED. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA VIA REFERENCE # 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 ON JUNE 07, 2010 FOR A SITE IN THE US. A (B)(6) 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
    762214 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLX AGFA HEALTHCARE CORPORATION IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1