BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4455425 · Received October 27, 2014

    Report

    Report Number
    1225058-2014-02229
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 29, 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 CUSTOMIZATION HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: ECHO R.1.1.1 - INCORRECT MEASUREMENT SENTENCE IMPORT: THE SENTENCE "THE AORTIC VALVE AREA, BY PEAK VELOCITIES IS CALCULATED AT ( ) CM2." GENERATES A MEASUREMENT FROM AORTIC VALVE CROSS SECTIONAL AREA, NOT PEAK VELOCITY. THE POTENTIAL IMPACT OF THIS INCORRECT MEASUREMENT SENTENCE IS: INCORRECT AORTIC VALVE AREA METHOD WILL BE DISPLAYED IN THE SENTENCE WITH A POTENTIAL OF UNDER OR OVER ESTIMATING THE AORTIC VALVE AREA BY PEAK VELOCITY. OR THE VALUE MAY NOT BE PRESENTED IN A SENTENCE, WHICH CREATES THE POTENTIAL FOR MISDIAGNOSIS OF DISEASE STATUS. 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. THE SPECIFIC STUDY DATE AND MEDICAL RECORDS NUMBER/S FOR THIS MDR ARE: MRN: (B)(6); STUDY DATE:(B)(6) 2011.

    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 2,828 DIFFERENT STUDY DATES FROM YEARS 2005 TO OCTOBER 2014, IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN). CURRENTLY, 10,266 REPORTS CONTAIN THIS INCORRECT FINDING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685770 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) LLZ AGFA CORP IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1