BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3782137 · Received April 30, 2014

    Report

    Report Number
    1225058-2014-00257
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 30, 2014
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AGFA IS SUBMITTING THIS MDR ON (B)(4) 2014. AGFA'S AWARENESS DATE IS (B)(6) 2014 FOR THIS EVENT. AGFA SUBMITTED MDR REPORT # 1225058-2010-00001 TO THE FDA ON (B)(4),2010 FOR A CUSTOMER IN THE US. AN 8TH 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. 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 ONE SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: THE FINDINGS CODE DOES NOT COINCIDE WITH THE FINDINGS SENTENCE. WHEN THE 2 MINUTE FINDING LABEL IS SELECTED IN STAGE 3 EXERCISE STRESS DURATION, THE REPORT GENERATES THE FOLLOWING STATEMENT: "THE TOTAL EXERCISE DURATION WAS 1 MINUTE." THIS RESULTS IN AN INCORRECT SENTENCE FINDING THAT SHOWS IN THE REPORT THAT MAY NOT BE OBVIOUS TO THE READER. THE INTENDED "2 MINUTES" SHOWS AS "1 MINUTE". AGFA INVESTIGATION INTO THE SITE'S IMPAX CV DATABASE HAS CONFIRMED THAT NO PATIENT REPORTS CURRENTLY CONTAIN THIS INCORRECT FINDING SENTENCE; THEREFORE, NO PATIENTS HAVE BEEN IMPACTED BY THIS CHANGE. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # IS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260419 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP. IMPAX CV 2.08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1