FDA Adverse Event Injury Summary report: N

FREESTYLE LITE

MDR report key: 2132903 · Received June 17, 2011

Report

Report Number: 2954323-2011-03587
Event Type: Injury
Date Received: June 17, 2011
Date of Event: May 12, 2011
Report Date: June 17, 2011
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS A FINAL REPORT. COMPLAINT INVOLVED A TRAINING ISSUE; HENCE THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THEREFORE NO INVESTIGATION OF THE PRODUCT IS REQUIRED.

Description of Event or Problem · 1

CUSTOMER CALLED CUSTOMER SERVICE TO REQUEST ASSISTANCE SETTING UP HIS FREESTYLE LITE BLOOD GLUCOSE METER. WHILE ON THE PHONE CUSTOMER REPORTED THAT ON (B)(6) 2011 HE WAS EXTREMELY TIRED AND BELIEVED HIS BLOOD GLUCOSE WAS HIGH, BUT WAS UNABLE TO TEST DUE TO THE METER NOT BEING SET-UP. CUSTOMER SELF-PRESENTED TO HIS HEALTHCARE PROVIDER AND WAS DIAGNOSED WITH "A TOE INFECTION THAT LED TO AN INFECTION IN THE BLOOD". CUSTOMER WAS TREATED WITH AN UNKNOWN AMOUNT OF INSULIN AND UNSPECIFIED ANTIBIOTICS, WHICH WAS A CHANGE TO HIS NORMAL MEDICATION REGIMEN. CUSTOMER ADDITIONALLY SELF-TREATED WITH INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FREESTYLE LITE	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1024205

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention