Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; CALCULATOR, DRUG DOSE
  • 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; CALCULATOR, DRUG DOSE Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Death (1802); Hypoglycemia (1912)
Event Type  No Answer Provided  
Event Description
Description: i believe the insulin dosing program called endotool is causing devastating patient outcomes because of its aggressive drops in blood glucose greater than 200 mg/di/hr.Most hospital have max rates of 100 mg/dl/hr or less.These drastic reductions in blood glucose is causing rapid metabolic changes in which patients are requiring intubation and develop ekg changes.During the month of "xxxxx" we had several unfortunate outcomes including one patient death.I have reported all three patients to our quality assurance team.I spoke with the clinical team of the pharmacy and spoke with the head of the icu.Sadly there have been no changes that would prevent another patient from being harmed.I work in the emergency room.I would like my report to remain completely confidential.Medication administered to or used by the patient: yes.Outcome: during the month of "xxxxx" we had several unfortunate outcomes including one patient death.Where did the error occur: hospital.Patient counseling provided: unknown.Reporter's recommendations: i have reported all three patients to our quality assurance team.I spoke with the clinical team of the pharmacy and spoke with the head of the icu.Sadly there have been no changes that would prevent another patient from being harmed.Severity: error resulted in pt death.Relevant materials provided: none.Ismp, (b)(6), access number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOTOOL
Type of Device
CALCULATOR, DRUG DOSE
Manufacturer (Section D)
MONARCH MEDICAL TECHNOLOGIES
MDR Report Key10294858
MDR Text Key199839026
Report NumberMW5095572
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
-
-