MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL SUBQ; ENDOTOOL SUBQ 1.7X

Model Number SUBQ VERSIONS 1.7X

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ENDOTOOL SUBQ
• Type of Device: ENDOTOOL SUBQ 1.7X
• Manufacturer (Section D): MONARCH MEDICAL TECHNOLOGIES; 4400 stuart andrew blvd; charlotte, nc
• Manufacturer (Section G): MONARCH MEDICAL TECHNOLOGIES; 4400 stuart andrew blvd.; charlotte, nc
• Manufacturer Contact: brian johnson ; 4400 stuart andrew blvd; charlotte, nc ; 5249660
• MDR Report Key: 9877394
• MDR Text Key: 208141501
• Report Number: 3009864844-2020-90001
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUBQ VERSIONS 1.7X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2018
• 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