BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUNG (RESULTS MANAGEMENT 2.08)

    MDR report key: 4565103 · Received December 4, 2014

    Report

    Report Number
    1225058-2014-06433
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 4, 2014
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Product Code
    LLZ
    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 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: 1.2.1 TWO-FOLD ISSUE: ORIGINAL SENTENCE "THE MEAN LEFT VENTRICULAR OUTFLOW TRACT GRADIENT IS" WAS CHANGED TO "THE PEAK LEFT VENTRICULAR OUTFLOW GRADIENT WITH VALSALVA IS ( ) MMHG." CHANGING ITS MEANING; AND THE MEASUREMENT BEING IMPORTED INTO THE SENTENCE IS A MEAN GRADIENT, NOT A PEAK GRADIENT. POTENTIAL IMPACT: THE WORSE CLINICAL IMPACT IS THAT THE PRESSURE POPULATING THE SENTENCE WOULD UNDERESTIMATE THE CORRECT GRADIENT, POTENTIALLY LEADING TO MISDIAGNOSIS AND/OR INCORRECT TREATMENT. IN ADDITION, 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 USED AS A TEMPLATE FOR A REPEAT STUDY ON THAT PT, OR IF RE-SIGNED AT A LATER DATE. THE PEAK GRADIENT MEASURED WITH ECHO IS THE MAXIMUM VELOCITY (PRESSURE DIFFERENCE) ACROSS THE VALVE DURING THE ENTIRE SYSTOLIC EJECTION PERIOD. THE MEAN PRESSURE GRADIENT IS THE AVERAGE DIFFERENCE IN PRESSURES OVER THE DURATION OF FLOW. THE VALSALVA MANEUVER IS PERFORMED BY MODERATELY FORCEFUL ATTEMPTED EXHALATION AGAINST A CLOSED AIRWAY, USUALLY DONE BY CLOSING THE MOUTH, AND PINCHING THE NOSE SHUT WHILE PRESSING OUT AS IF BLOWING UP A BALLOON. VARIATIONS OF THE MANEUVER CAN BE USED EITHER IN MEDICAL EXAMINATION/PROCEDURES AS A TEST OF CARDIAC FUNCTION. THERE IS A CLINICALLY DIFFERENT MEANING FOR A PEAK VS A MEAN GRADIENT VALUE. THE INTENT FOR THE SENTENCE FINDING WAS TO INCLUDE THE MEAN GRADIENT, BUT INSTEAD, THE SENTENCE WAS CHANGED TO STATE PEAK GRADIENT WHILE ACTUALLY PULLING IN THE INTENDED MEAN AND ADDING THAT THE VALSALVA MANEUVER WAS PERFORMED. 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 14TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT). WITHIN THIS 14TH OCCURRENCE ARE 122 DIFFERENT STUDY DATES IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN). CURRENTLY, 131 REPORTS CONTAIN THIS INCORRECT FINDING INFORMATION. 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
    785619 IMPAX CV OUTBOUNG (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORPORATION IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1