FDA Adverse Event Injury Summary report: N

OT ULTRA METER

MDR report key: 1971719 · Received January 27, 2011

Report

Report Number: 2939301-2011-00888
Event Type: Injury
Date Received: January 27, 2011
Date of Event: January 25, 2011
Report Date: January 26, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GR
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE 510 (K) # IS K011479. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. 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

THE REPORTER CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING MISSING SEGMENTS ON HER DAUGHTER'S ONE TOUCH ULTRA METER. THE ALLEGED ISSUE WITH THE METER BEGAN APPROXIMATELY 6 MONTHS AGO. DUE TO THE ALLEGED ISSUE SHE HAS BEEN UNABLE TO TEST HER BLOOD GLUCOSE. ON (B)(6) 2011 AT 12:00PM, WHILE THE PATIENT WAS AT SCHOOL, SHE DEVELOPED SYMPTOMS OF TREMBLING ALL OVER AND EXPERIENCED A HEADACHE. THAT MORNING AT 8:00AM, SHE HAD TAKEN HER NORMAL DOSAGE OF INSULIN (22 UNITS). THE PATIENT WENT HOME AT 12:30 PM AND TESTED ON HER GRANDMOTHER'S ULTRA METER AND OBTAINED A 45 MG/DL. AT 1:30 PM SHE ATE LUNCH AND HER SYMPTOMS WENT AWAY AFTER EATING. SHE DID NOT RETEST OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED ISSUE, WITH THE METER, HER DAUGHTER WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND HAD TO SELF-TREAT WITH FOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRA METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3018989

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR		Life Threatening\| R