• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MONARCH MEDICAL TECHNOLOGIES ENDOTOOL SUBQ ENDOTOOL SUBQ 1.7X Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOTOOL SUBQ
Type of DeviceENDOTOOL 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 Key9877394
MDR Text Key208141501
Report Number3009864844-2020-90001
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received03/25/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSUBQ VERSIONS 1.7X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/25/2020 Patient Sequence Number: 1
-
-