ENDOTOOL

Report

Report Number: 3009864844-2012-00002
Event Type: Other
Date Received: November 26, 2012
Date of Event: October 31, 2012
Report Date: November 26, 2012
Manufacturer: ENDOTOOL LLC
Product Code: NDC
PMA / PMN Number: K053137
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

BOTH PTS WERE JUST STARTED ON ENDOTOOL USING THE "START FROM IV INSULIN" RADIO BUTTON. THE RN CALLED ENDOTOOL WHEN HE/SHE RECEIVED NO DOSE. I INSTRUCTED THEM TO DELETE THE READING IN ENDOTOOL, REPEAT THE GLUCOSE AND THEN SELECT "ENDOTOOL TO CALCULATE¿" RADIO BUTTON. THE NURSE DID SO AND PUT IN A BG AND RECEIVED A DOSE OF INSULIN FOR THE PT.

Additional Manufacturer Narrative · 1

BOTH PTS WERE JUST STARTED ON ENDOTOOL USING THE "START FROM IV INSULIN" RADIO BUTTON. THE RN CALLED ENDOTOOL WHEN HE/SHE RECEIVED NO DOSE. I INSTRUCTED THEM TO DELETE THE READING IN ENDOTOOL, REPEAT THE GLUCOSE AND THEN SELECT "ENDOTOOL TO CALCULATE¿" RADIO BUTTON. THE NURSE DID SO AND PUT IN A BG AND RECEIVED A DOSE OF INSULIN FOR THE PT.

Description of Event or Problem · 1

TWO EVENTS OF POSSIBLE MALFUNCTION OF THE ENDOTOOL DRUG DOSE CALCULATOR OCCURRED ON THE DATES STATED ABOVE AT THE SAME HOSP. THE FIRST INCIDENT THE ENDOTOOL SYS DID NOT CALCULATE A DOSE FOR THE PT FOR ALMOST TWO DAYS WITH A BLOOD GLUCOSE LEVEL OF 170. IN THE SECOND INCIDENT A PT DID NOT GET A DOSE CALCULATED OR RECEIVE A DOSE OF INSULIN WITH A BLOOD GLUCOSE OF 160. THE NURSE WAS CALLED AND ENDOTOOL WAS CONTACTED. THE CLINICAL COORDINATE INSTRUCTED THE NURSE TO DELETE THE READING IN ENDOTOOL, REPEAT THE GLUCOSE AND TO PRESS THE CALCULATE RATION BUTTON. THE PT WAS THEN DOSED. A 45 MINUTE DELAY IN DOSING OCCURRED. NO HYPER OR HYPO-GLYCEMIA OCCURRED IN EITHER PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTOOL	BLOOD GLUCOSE DOSE CALCULATOR	NDC	ENDOTOOL LLC	VERSION 2.27

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention