ULTRASOFT LANCING DEV

Report

Report Number: 2939301-2010-05734
Event Type: Injury
Date Received: July 18, 2010
Date of Event: July 7, 2010
Report Date: July 7, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

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.SERIAL NUMBER: NOT PROVIDED.LOT NUMBER: NOT PROVIDED.

Description of Event or Problem · 1

ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE LANCET WITH THE ONE TOUCH ULTRASOFT LANCING DEVICE WOULD NOT FULLY PENETRATE THE SKIN. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 3:00 PM, THE PATIENT NOTED THE REPORTED LANCING DEVICE'S LANCET WOULD NOT FULLY PENETRATE HER SKIN; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THREE HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, SWEATING AND SLURRED SPEECH. THE PATIENT CONSUMED MORE FOOD AND/OR DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES WITH VICTOZA (LIRAGLUTIDE), NOVOLOG INSULIN AND LANTUS INSULIN. THE LANCING DEVICE WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO OBTAIN A BLOOD SAMPLE FOR GLUCOSE TESTING DUE TO THE LANCING DEVICE ISSUE, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULTRASOFT LANCING DEV	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Life Threatening\| R