BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4113611 · Received February 28, 2014

    Report

    Report Number
    1225058-2014-00039
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLZ
    PMA / PMN Number
    K050858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AGFA IS CURRENTLY REVIEWING THE RMAT LOGS TO IDENTIFY WHEN THE CUSTOMIZATION CHANGE WAS INTRODUCED INTO THE PRODUCTION ENVIRONMENT. (B)(4). AGFA'S CLINICAL ANALYST ALSO DETERMINED FROM A STUDY SELECTED FROM THE POTENTIALLY AFFECTED RMAT LOG, THAT THE INCORRECT SENTENCE FINDING LINE WAS LOCATED DIRECTLY ABOVE THE ACTUAL MEASUREMENTS (WHICH ARE CORRECT) AND THAT A USER WOULD BE MORE LIKELY TO LOOK AT THE ACTUAL MEASUREMENTS IN A REPORT TO FORMULATE CONCLUSIONS AND TREATMENT DECISIONS; AN INCLINATION AS TO WHY THE READING PHYSICIANS MISSED THE INCORRECT SENTENCE FINDING OF "HYPOTENSION" VERSUS "HYPERTENSION " IN THE MANY PREVIOUS PULMONARY ARTERY PATHOLOGY REPORTS. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE# IS Z-2112-10. ANY FURTHER INVESTIGATION FOR THE SITE DESCRIBED IN THIS REPORT WILL BE DOCUMENTED IN THE ONGOING CFR PART 806 REPORTING. (B)(4).

    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 7TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT). THE CUSTOMER, THE INITIAL REPORTER, IN THIS NEW EVENT CONTACTED AGFA ON (B)(6) 2014 AND REPORTED A READING PHYSICIAN HAD DISCOVERED AN INCORRECT STATEMENT IN THE PULMONARY ARTERY FINDINGS WITHIN THEIR RMAT REPORTING. THE CUSTOMER CONFIRMED THERE WERE NO REPORTS OF PATIENT HARM DURING THIS EVENT. THE CUSTOMER STATED NO RMAT CUSTOMIZATION REQUESTS HAD BEEN MADE TO AGFA, AND THE SITE'S SUPER USER HAD NOT MADE ANY CUSTOM CHANGES TO THE PULMONARY ARTERY FINDINGS WITHIN THE REPORTING TOOL, ABIDING BY AGFA'S RMAT TERMS OF USE. THE CUSTOMER DESCRIBED WHEN REPORTS WERE CREATED FOR TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE), TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND STRESS (STR) STUDIES, AND WHEN THE END-USER SELECTED THE "MILD TO MODERATE" RADIO BUTTON IN THE PULMONARY ARTERY PATHOLOGY SECTION, THE INCORRECT SENTENCE FINDING OF "THERE IS MILD TO MODERATE PULMONARY HYPOTENSION" WAS GENERATED IN THE REPORT. THE SENTENCE FINDING SHOULD READ "THERE IS MILD TO MODERATE PULMONARY HYPERTENSION." THE SAME DAY THE CUSTOMER REPORTED THE EVENT, AGFA CORRECTED THE STATEMENT IN BOTH THE TEST AND PRODUCTION ENVIRONMENTS AND; IN TURN, THE CUSTOMER REVIEWED THE CORRECTION AND CONFIRMED THE STATEMENT WAS READING CORRECTLY WITH "HYPERTENSION" VERSUS "HYPOTENSION". AGFA CONFIRMED RMAT SUPER USER WAS DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125447 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