BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4544282 · Received November 14, 2014

    Report

    Report Number
    1225058-2014-04034
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 14, 2014
    Manufacturer
    AGFA CORP.
    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 CUSTOMIZATIONS HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: ORIGINAL MEASUREMENT LABEL WAS "AO SINUSES (A4C)" - THIS WAS CHANGED TO "VSD". 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 PT - IN THIS EXAMPLE THE TWO DISEASE STATES ARE VERY DIFFERENT, LEADING TO POTENTIAL INCORRECT DIAGNOSIS. ALSO, IF THE MEASUREMENT (ID/HLCODE) IS USED TO POPULATE A FINDINGS SENTENCE IN THE SYSTEM, ALL REPORTS MADE AFTER THE EDIT WITH THE FINDING AND MEASUREMENT SELECTED WILL ALSO BE AFFECTED. AS STATED ABOVE, IF THE CHANGE WAS MADE AFTER REPORTS HAD BEEN GENERATED WITH THE ORIGINAL SENTENCE FINDING, THE EXPECTED MEASUREMENT LABEL OF "AO SINUSES (A4C)" (AORTIC SINUSES IN APICAL 4 CHAMBER VIEW) WOULD BE CHANGED TO A COMPLETELY DIFFERENT LABEL OF "VSD" (VENTRICULAR SEPTAL DEFECT), WHICH AS STATED COULD POTENTIALLY LEAD TO AN INCORRECT DIAGNOSIS. AN AORTIC SINUS IS ONE OF THE ANATOMIC DILATIONS OF THE ASCENDING AORTA, WHICH OCCURS JUST ABOVE THE AORTIC VALVE. THERE ARE GENERALLY THREE AORTIC SINUSES: THE LEFT, THE RIGHT AND THE POSTERIOR SINUSES. A VENTRICULAR SEPTAL DEFECT (VSD) IS A DEFECT IN THE VENTRICULAR SEPTUM, THE WALL DIVIDING THE LEFT AND RIGHT VENTRICLES OF THE HEART. THERE HAS BEEN NO REPORTED PT 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 12TH 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 12TH OCCURRENCE ARE 956 DIFFERENT STUDY DATES FROM YEARS 2010 TO 2014, IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN). CURRENTLY, 1774 REPORTS CONTAIN THIS INCORRECT FINDING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739355 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) LLZ AGFA CORP. IMPAX CV. 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1