BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTOOL SUBQ

    MDR report key: 9877394 · Received March 25, 2020

    Report

    Report Number
    3009864844-2020-90001
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    July 28, 2018
    Report Date
    March 17, 2020
    Manufacturer
    MONARCH MEDICAL TECHNOLOGIES
    Product Code
    NDC
    PMA / PMN Number
    K180366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL FACILITIES CURRENTLY USING ENDOTOOL SUB Q 1.7.X HAVE BEEN NOTIFIED TO DISCONTINUE USE OF THE DISCHARGE REPORT AND HAVE BEEN PROVIDED INSTRUCTIONS FOR UTILIZING OTHER TOOLS AVAILABLE IN THE SOFTWARE TO VIEW THE TDD AND PATIENT HISTORY.

    Description of Event or Problem · 1

    A SOFTWARE BUG WAS DISCOVERED IN ENDOTOOL SUBQ 1.7.X CAUSING THE DISCHARGE/TRANSITION REPORT TO OCCASIONALLY DISPLAY INACCURATE TDD (TOTAL DAILY DOSE) OF INSULIN INFORMATION. THE DISCHARGE/TRANSITION REPORTS PROVIDE A SUMMARY OF THE HOSPITALIZED PATIENT'S TDD AND NUTRITION PLAN OVER THE PAST 24 HOURS. MONARCH HAS NOT RECEIVED ANY INFORMATION OR INDICATION THAT THIS MALFUNCTION HAS CAUSED OR CONTRIBUTED TO SERIOUS INJURY OR DEATH. UPON RECEIVING ADDITIONAL INFORMATION INDICATING THAT SOME PHYSICIANS MAY BE USING THE TDD ON THE DISCHARGE/TRANSITION REPORT AS A DOSE RECOMMENDATION, MONARCH CONDUCTED A RETROSPECTIVE REVIEW OF COMPLAINTS INVOLVING THE DISCHARGE/TRANSITION REPORT ERROR AND MADE A DETERMINATION TO SUBMIT THIS MDR. MONARCH HAS NOTIFIED ALL CUSTOMERS USING THE SOFTWARE TO DISCONTINUE USE OF THE DISCHARGE/TRANSITION REPORT UNTIL FURTHER NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344003 ENDOTOOL SUBQ ENDOTOOL SUBQ 1.7X NDC MONARCH MEDICAL TECHNOLOGIES SUBQ VERSIONS 1.7X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other