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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL CALCULATOR, DRUG DOSE

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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).
 
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Brand NameENDOTOOL
Type of DeviceCALCULATOR, 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
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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