BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 4279751 · Received November 19, 2014

    Report

    Report Number
    1225058-2014-03250
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 14, 2014
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Removal / Correction Number
    Z-2112-10
    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 OCCURENCE OF RMAT CUSTOMIZATION HAS REVEALED THAT THIS SPECIFIC CHANGE HAD THE POTENTIAL TO INTRODUCE CLINICAL INACCURACIES IN PATIENT REPORTS. SPECIFICALLY: ORIGINAL MEASUREMENT LABEL WAS "PDK PK VEL". POTENTIAL IMPACT: IF THE CHANGE WAS MADE AFTER REPORTS HAD BEEN GENERATED WITH THE ORIGINAL SENTENCE SELECTED, THOSE REPORTED PRIOR TO THE CHANGE COULD DISPLAY INCORRECT CLINICAL DATA IF VIEWED IN RM OR IF USED AS A TEMPLATE FOR A REPEAT STUDY ON THAT PATIENT - IN THIS EXAMPLE THE TWO DISEASE STATES ARE VERY DIFFERENT, LEADING TO POTENTIAL INCORRECT DIAGNOSIS. ON (B)(4) 2014: ALSO, IF THE MEASUREMENT (ID/HLCODE) IS USED TO POPULATE A FINDINGS SENTENCE IN THE SYSTEM, ALL REPORTS MADE AFTER THE EDIT WITH THE FINDING AND MEASUREMENT SELECTED WILL ALSO BE AFFECTED. AS STATED ABOVE, IF THE CHANGE WAS MADE AFTER REPORTS HAD BEEN GENERATED WITH THE ORIGINAL SENTENCE OF "SUP MEAN VEL" SELECTED, THE MEASUREMENT LABEL WHICH WAS INTENDED BY THE READING PHYSICIAN WOULD BE CHANGED TO A VERY DIFFERENT LABEL OF "PDA PK VEL", WHICH REFERENCES A PT DUCTUS ARTERIOSUS (PDA) PEAK VELOCITY RATHER THAN THE SUP MEAN VELOCITY THAT WAS ORIGINALLY INTENDED. THE INCORRECT LABEL COULD CAUSE CONFUSION TO THE END USER AND RESULT IN DELAYED TREATMENT OR AN INCORRECT DIAGNOSIS. THERE HAS BEEN NO REPORTED PATIENT 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)(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 12TH OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTED 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 ONE STUDY DATE FOR (B)(6) 2010, IN WHICH (B)(6) MEDICAL RECORD NUMBER (MRN) CONTAINS THIS INCORRECT FINDING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750522 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP IMPAX CV 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1