BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTOOL IV

    MDR report key: 8742385 · Received June 27, 2019

    Report

    Report Number
    3009864844-2019-00002
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    December 15, 2017
    Report Date
    June 27, 2019
    Manufacturer
    MONARCH MEDICAL TECHNOLOGIES
    Product Code
    NDC
    PMA / PMN Number
    K132547
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO MONARCH MEDICAL'S KNOWLEDGE, THE ALLEGED COMPLAINT HAS NOT RE-OCCURRED.

    Description of Event or Problem · 1

    ENDOTOOL WEB IV VERSION 1.8.6 SUPPORT CASE CREATED FOR CUSTOMER INQUIRY REGARDING A HYPOGLYCEMIC EVENT AND THE SOFTWARE'S RECOMMENDED DOSE OF RECOVERY CARBOHYDRATES. THE ORIGINAL INVESTIGATION OF THIS CASE WAS INCONCLUSIVE. CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION AND LATER ADVISED THE CASE WOULD BE CLOSED AND RE-OPENED AT THEIR REQUEST. ADDITIONAL CASE FOR ENDOTOOL WEB IV VERSION 1.7 FOR A CUSTOMER INQUIRY REGARDING A HYPOGLYCEMIC EVENT AND THE SOFTWARE'S RECOMMENDED DOSE FOR IV INSULIN. RETROSPECTIVE REVIEW OF THESE CASES HAS RESULTED IN A DETERMINATION TO NOW SUBMIT THIS MDR. IN BOTH CASES, USER ERROR CONTRIBUTED TO THE HYPOGLYCEMIC EVENT. IN THE WEB IV VERSION 1.8.6 CASE, THE ENDOTOOL-RECOMMENDED CARBOHYDRATE TREATMENT WAS NOT FOLLOWED AND THE PATIENT SOON HAD A HYPOGLYCEMIC READING. FOR THE WEB IV VERSION 1.7 CASE, THE USER RETURNED TO THE APPLICATION WITHIN 5 MINUTES OF THE PREVIOUS RECOMMENDATION AND ENTERED A NEW BLOOD GLUCOSE READING. ACCORDING TO ENDOTOOL LABELING AND FUNCTIONALITY THIS WAS TOO SOON TO GET AN ACCURATE DRIP RECOMMENDATION AND THE PATIENT HAD A HYPOGLYCEMIC EVENT. FOR BOTH CASES THERE WAS NO PATIENT HARM. ALSO IN BOTH CASES, IF THE USER WOULD HAVE FOLLOWED GUIDANCE FROM THE ENDOTOOL WEB IV APPLICATION THE EVENTS COULD HAVE BEEN PREVENTED. USERS HAVE BEEN RE-EDUCATED ON PROPER USE OF THE SOFTWARE. ALTHOUGH OUR FINDINGS NOW INDICATE THAT ENDOTOOL DID NOT MALFUNCTION IN EITHER CASE, MONARCH IS DEVELOPING ADDITIONAL USER EDUCATIONAL MATERIALS TO MITIGATE THESE USER ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533448 ENDOTOOL IV ENDOTOOL IV NDC MONARCH MEDICAL TECHNOLOGIES WEB IV SOFTWARE VERSION 1.8.6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other