MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV

Model Number IV SOFTWARE VERSIONS 1.8.5 AND HIGHER

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Type  malfunction  

Manufacturer Narrative

All affected customer sites have been notified of the software bug.A patch was created and validated for endotool iv versions 1.8.5 and higher.The affected customer sites are being upgraded.

Event Description

A software bug was discovered in endotool iv version 1.10.This bug is in an area of the software that addresses persistently elevated glucose levels.Investigation and analysis of the bug has determined it is very unlikely to re-occur.In the very unlikely event it does re-occur, it could cause the software to incorrectly calculate an insulin dose recommendation.Investigation determined there has been only one occurence of the bug.The dose recommendation was correctly not accepted by the bedside caregiver and there was no associated patient harm.All affected customer sites have been notified of the software bug.A patch was created and validated for endotool iv versions 1.8.5 and higher.The affected customer sites are being upgraded.

• 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: 8649269
• MDR Text Key: 146484051
• Report Number: 3009864844-2019-00001
• 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: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IV SOFTWARE VERSIONS 1.8.5 AND HIGHER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/29/2019
• 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
• Removal/Correction Number: 3009864844-5/9/2019-001C
• Patient Sequence Number: 1