FDA Adverse Event Injury Summary report: N

ONE TOUCH ULTRAMINI METER

MDR report key: 1243795 · Received November 24, 2008

Report

Report Number: 2939301-2008-03204
Event Type: Injury
Date Received: November 24, 2008
Date of Event: November 8, 2008
Report Date: November 10, 2008
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ND, US
Reporter Occupation: LAY USER/PATIENT

Narratives

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI DISPLAYED THE "ER1" MESSAGE FOR THE FIRST TIME TWO DAYS PRIOR, AFTERNOON. APPROXIMATELY ONE HOUR AFTER THE ERROR MESSAGE,THE PT REPORTEDLY HAD A SEIZURE. HE WAS GIVEN SUGAR CUBES BY AN UNSPECIFIED PERSON AND REPORTEDLY "CAME OUT OF IT". DETAILS REGARDING EVENTS LEADING TO THE SEIZURE, SUCH AS HIS ACTIVITY LEVELS, FOOD INTAKE, MEDICATIONS AND PREVIOUS METER READINGS WERE NOT REPORTED. THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PT THROUGH TROUBLESHOOTING AND NOTED THAT THE ERROR MESSAGE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. SINCE THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PT FOR ADD'L INFO, THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CCA'S DOCUMENTATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY WENT INTO SEIZURE ONE HR AFTER THE ERROR MESSAGE OCCURRED. IN ADDITION, THE ERROR MESSAGE WAS NOT RESOLVED WITH TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONE TOUCH ULTRAMINI METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.	NA	2847162

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening\| R