FDA Adverse Event Summary report: N

ENDOTOOL

MDR report key: 10294858 · Received July 17, 2020

Report

Report Number
MW5095572
Date Received
July 17, 2020
Report Date
July 17, 2020
Manufacturer
MONARCH MEDICAL TECHNOLOGIES
Product Code
NDC
Report Source
Voluntary report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
757056 ENDOTOOL CALCULATOR, DRUG DOSE NDC MONARCH MEDICAL TECHNOLOGIES

Patients

Seq Age Sex Outcome Treatment
1