BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGON LABORATORY MANAGEMENT

    MDR report key: 4861735 · Received June 18, 2015

    Report

    Report Number
    3010034769-2015-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FINAL CUMULATIVE REPORT IS USED TO SUMMARIZE THE COMPLETE HISTORY OF PARAGON LABORATORY MANAGEMENT (PLM) TEST RESULTS FOR THE PT HOSP STAY; IT IS TYPICALLY GENERATED AT THE END OF THE PT STAY (AT DISCHARGE) AND IS FILED IN THE PT FOLDER. THIS REPORT IS NOT TYPICALLY USED DURING THE ACTIVE PHASE OF PT TREATMENT, AS THERE ARE OTHER REPORTS GENERATED BY PLM THAT ARE USED FOR ACTIVE PT TREATMENT AND THEY ARE UNAFFECTED BY THIS ISSUE. IF THE PT IS DISCHARGED AND IS TRANSFERRED TO ANOTHER CLINICAL FACILITY FOR ADD'L/FOLLOW-UP TREATMENT, THE FINAL CUMULATIVE REPORT MAY BE USED BY THE SECOND CLINICAL FACILITY TO DETERMINE CARE/TREATMENT. IF THE DATA IS NOT REPORTED ACCURATELY, THERE IS THE REMOTE POTENTIAL FOR PT HARM. CUSTOMERS WOULD ONLY ENCOUNTER THIS ISSUE AFTER UPGRADING FROM (B)(6) SQL SERVER 2008 TO (B)(6) SQL SERVER 2012. THIS ISSUE IS A RESULT OF A CHANGE IN DATA HANDLING IN (B)(6) SQL SERVER 2012. MCKESSON IS ADVISING CUSTOMERS OF THE ISSUE, AND WILL PROVIDE MITIGATION THROUGH SOFTWARE UPDATES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN USING PARAGON LABORATORY MANAGEMENT RELEASE 12.1 AFTER UPGRADING TO (B)(6) SQL SERVER 2012, THEY HAD A PROBLEM GENERATING AN ACCURATE FINAL CUMULATIVE REPORT. THE DATA DISPLAY IN THE FINAL CUMULATIVE REPORT DID NOT MATCH THE DATA DISPLAY EXPECTED FROM THE DATABASE INFO. THE TEST RESULTS WERE CORRECT AND THE DATA/TIME STAMP VALUES WERE CORRECT, BUT THE REPORT DISPLAY SHOWED A MISMATCH IN THE TEST RESULT VALUE REPORTED AGAINST THE DATE/TIME STAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396404 PARAGON LABORATORY MANAGEMENT LABORATORY INFO SYSTEM JQP MCKESSON TECHNOLOGIES INC. 12.1, 12.1.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other