MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV

Model Number WEB IV SOFTWARE VERSION 1.8.6

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

To monarch medical's knowledge, the alleged complaint has not re-occurred.

Event Description

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.

• Brand Name: ENDOTOOL IV
• Type of Device: ENDOTOOL IV
• Manufacturer (Section D): MONARCH MEDICAL TECHNOLOGIES; 2137 south blvd.; suite 300; charlotte NC 28203
• Manufacturer (Section G): MONARCH MEDICAL TECHNOLOGIES; 2137 south blvd; suite 300; charlotte NC 28203
• Manufacturer Contact: bruce lisanti ; 2137 south blvd.; suite 300; charlotte, NC 28203 ; 8553637475
• MDR Report Key: 8742385
• MDR Text Key: 213918818
• Report Number: 3009864844-2019-00002
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WEB IV SOFTWARE VERSION 1.8.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other