BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4285923 · Received November 7, 2014

    Report

    Report Number
    1225058-2014-03204
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 7, 2014
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CUSTOMIZATION HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: ORIGINAL FINDING/SENTENCE/SHORT DESCRIPTION IN THE STUDY INDICATION WAS A FOLLOW-UP STUDY FOR "AOV, BICUSPID" - THIS WAS CHANGED TO A REGULAR INDICATION OF "AORTIC VALVE DISEASE". THE NORMAL AORTIC VALVE HAS 3 EQUAL-SIZED LEAFLETS OR CUSPS WITH 3 LINES OF COAPTATION. A CONGENITALLY BICUSPID AORTIC VALVE HAS 2 FUNCTIONAL LEAFLETS. MOST HAVE ONE COMPLETE LINE OF COAPTATION. APPROX HALF OF CASES HAVE A LOW RAPHE. THERE IS A CLINICALLY SIGNIFICANT DIFFERENCE BETWEEN A BICUSPID AORTIC VALVE WHICH IS A VERY SPECIFIC ANATOMICAL ABNORMALITY VERSUS AORTIC VALVE DISEASE WHICH COULD ENCOMPASS A WIDE VARIETY OF AORTIC VALVE CONDITIONS SUCH AS REGURGITATION, STENOSIS, ETC. 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 - WHILE BICUSPID AORTIC VALVE IS ESSENTIALLY A PART OF AORTIC VALVE DISEASE, NOT SEEING THAT A PREVIOUS STUDY WAS PERFORMED AS A FOLLOW-UP FOR THIS SPECIFICALLY COULD LEAD TO CONFUSION. 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)(4).

    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 (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. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718655 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORPORATION IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1