BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTOOL IV

    MDR report key: 9980931 · Received April 21, 2020

    Report

    Report Number
    3009864844-2020-90002
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 21, 2020
    Manufacturer
    MONARCH MEDICAL TECHNOLOGIES
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD 1 WAS REMOVED FROM THE MOST-RECENTLY CLEARED VERSION OF ENDOTOOL IV. MONARCH HAS NOTIFIED ALL CUSTOMERS WHOSE PARAMETERS INCLUDE THE USE OF METHOD 1 OF THIS ISSUE, REMINDING THEM TO ALWAYS HAVE THE BASAL TRANSITION DOSING RECOMMENDATION VERIFIED BY A PHYSICIAN PRIOR TO ADMINISTERING THE DOSE. A TIP CARD HAS ALSO BEEN PROVIDED WITH THIS INFORMATION. TO ELIMINATE THE RISK OF THIS ISSUE RECURRING, MONARCH IS REQUESTING THAT CUSTOMERS UPGRADE TO THE NEWEST SOFTWARE VERSION OF THE ENDOTOOL IV (B)(4) APPLICATION, WHICH ONLY USES METHOD 0 TO CALCULATE TDD. CUSTOMERS WHO CANNOT UPGRADE SOON WILL BE OFFERED A PARAMETER ADJUSTMENT, SWITCHING FROM USE OF METHOD 1 TO METHOD 0 IN THEIR APPLICATION.

    Description of Event or Problem · 1

    MONARCH MEDICAL TECHNOLOGIES HAS RECEIVED COMPLAINTS FROM CUSTOMERS THAT THE BASAL TRANSITION DOSING RECOMMENDATION CALCULATED BY ENDOTOOL IV 1.8.0 - 1.10.1 APPLICATIONS WAS HIGHER THAN EXPECTED. NONE OF THE REPORTED CASES RESULTED IN PATIENT HARM, AS THE BEDSIDE CLINICIAN WAS ABLE TO EASILY RECOGNIZE THE DOSE AS BEING TOO HIGH. INVESTIGATION CONCLUDED THAT ONE OF THE METHODS USED FOR THE TDD (TOTAL DAILY DOSE) CALCULATION CAN RESULT IN AN ELEVATED BASAL TRANSITION DOSING RECOMMENDATION. THE REPORTING CUSTOMERS EACH HAD "METHOD 1" IN USE WHEN THEY RECEIVED ELEVATED BASAL TRANSITION DOSING RECOMMENDATIONS FROM THE APPLICATION. DUE TO RECURRENCE OF THIS INCIDENT, WE INITIATED AN INTERNAL REVIEW OF CASES AND FOUND THAT THE TDD METHOD 1 WAS THE CAUSE OF HIGH TRANSITION RECOMMENDATION IN THE PRIOR CASES, RESULTING IN MONARCH THE FILING A 30 DAY MDR FOR THIS ISSUE. THIS HAS BEEN CORRECTED IN THE NEXT VERSION OF THE SOFTWARE. CUSTOMERS HAVE BEEN INSTRUCTED TO SELECT A DIFFERENT TDD METHOD IN THE AFFECTED VERSIONS OF THE SOFTWARE UNTIL THEY ARE ABLE TO UPGRADE TO THE NEW VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447341 ENDOTOOL IV ENDOTOOL IV NDC MONARCH MEDICAL TECHNOLOGIES IV 1.8.0 -1.10.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other