BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4660887 · Received December 12, 2014

    Report

    Report Number
    1225058-2014-15636
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 12, 2014
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLX
    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 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 ORIGINAL SENTENCE OF "THERE IS MILD PROLAPSE OF THE TRICUSPID VALVE LEAFLETS" HAS BEEN CHANGED TO "THERE IS BOWING OF THE POSTERIOR LEAFLET OF THE TRICUSPID VALVE BUT NO EVIDENCE OF FRANK PROLAPSE." IN THIS ISSUE, THE ORIGINAL SENTENCE INDICATES PRESENCE OF MILD PROLAPSE. THE CHANGED SENTENCE DESCRIBES THE ABSENCE OF PROLAPSE AND STATES THAT THE POSTERIOR LEAFLET IS BOWING ONLY. THIS HAS A DIFFERENT CLINICAL MEANING AND COULD LEAD TO OVERESTIMATION OF DISEASE. 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. THERE HAS BEEN NO REPORTED PATIENT HARM FOR THIS OCCURRENCE. 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. (B)(6).

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT #1225058-2010-00001 TO THE FDA ON JUNE 7, 2010, FOR A SITE IN THE US. A 14TH 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 OCCURRENCE ARE 17 DIFFERENT STUDY DATES IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER/S (MRN) IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817884 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLX AGFA HEALTHCARE CORP IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1