FDA Adverse Event Injury Summary report: N

MEDTRONIC

MDR report key: 1589587 · Received January 26, 2010

Report

Report Number: MW5014531
Event Type: Injury
Date Received: January 26, 2010
Date of Event: December 7, 2009
Report Date: January 7, 2010
Manufacturer: MEDTRONIC MINIMED, INC.
Product Code: LZG
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WI, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

WHILE SLEEPING, THIS INSULIN PUMP DELIVERED A NEAR-FATAL DOSE OF INSULIN. THE PUMP'S HISTORY INDICATES THAT IT "THOUGHT" I ATE THE EQUIVALENT OF 20 SLICES OF BREAD AT 1 AM (90 MINUTES AFTER I WENT TO BED) AND THEN BEGAN DELIVERING 14.7 UNITS TO COVER THE CARBS, ALL IMPOSSIBLE AS I WAS ASLEEP. MY HUSBAND, A LIGHTSLEEPER, AND I BOTH KNOW I DID NOT INSTRUCT THE PUMP TO DO THIS. I SLEPT INTO A SERIOUS HYPOGLYCEMIC EVENT. THIS HUGE ERRONEOUS DOSE WAS SET TO BE DELIVERED OVER 8 HOURS ( I DISCOVERED THIS AND STOPPED IT AFTER 6 HOURS, FOLLOWING MY RECOVERY). HAD THE PUMP INSTEAD "DECIDED" TO DELIVER THE DOSE ALL AT ONCE, I WOULD HAVE DIED. A MORE COMPLETE DESCRIPTION OF THE EVENT, WITH DETAILED PUMP HISTORY, IS AVAILABLE FROM ME ON REQUEST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model
1	MEDTRONIC	INSULIN PUMP	LZG	MEDTRONIC MINIMED, INC.	PARADIGM 722
2	MEDRONIC GLUCOSE SENSOR	SENSOR	MDS	METRONIC MINIMED, INC.
3	MEDTRONIC TRANSMITTER	TRANSMITTER	MDS	MEDTRONIC MINIMED, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Life Threatening\| R	MEDTRONIC GLUCOSE SENSOR\| MEDTRONIC TRANSMITTER