BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3966453 · Received June 25, 2014

    Report

    Report Number
    1225058-2014-00351
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AGFA HEALTHCARE, CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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: FINING SENTENCE FOR FINDING ID = (B)(4). THIS ISSUE IS RELATED TO THE POTENTIAL FOR HISTORICAL REPORT CONTENT TO BE CHANGED IF RESIGNED OR PULLED FORWARD AS A TEMPLATE TO CREATE A NEW REPORT. THIS CONFIGURATION IN IMPAX CV REPORTING FOR THIS FINDING USED TO USE A MEAS_ID1025 WHICH IS A VELOCITY VALUE NOT A GRADIENT AS INDICATED IN THE FINDING SENTENCE. TODAY THE SENTENCE APPEARS WITHOUT A VALUE (THIS IS EVIDENT BECAUSE OF THE PARENTHESES ARE MISSING IN THE SENTENCE) MEANING THAT THIS ISSUE WOULD NOT BE CREATED IN A NEW REPORTED CREATED BY A CUSTOMER TODAY. HOWEVER, OLDER REPORTS WHICH WERE CREATED PRIOR TO THE REMOVAL OF THE MEAS_ID VALUE WOULD CONTAIN A MEASURE THAT IS NOT CONSISTENT WITH THE FINDING SENTENCE. (B)(4). NO PATIENT HARM HAS BEEN REPORTED DUE TO THIS EVENT. 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.

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT # 1225058-2010-00001 TO THE FDA ON 06/07/2010 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 CORRECTIONS PLAN, RMAT VERIFICATION, AS REPORTED IN FDA Z-2112-10. WITHIN THIS (B)(6) OCCURRENCE ARE 15 DIFFERENT STUDY DATES, IN WHICH AN INDIVIDUAL MDR REPORT WILL BE SUBMITTED FOR EACH ASSOCIATED STUDY DATE AND MEDICAL RECORD NUMBER (MRN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370549 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE, CORP. IMPAX CV RM 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1