FDA Adverse Event Injury Summary report: N

FREESTYLE FREEDOM LITE

MDR report key: 2092066 · Received May 18, 2011

Report

Report Number: 2954323-2011-03300
Event Type: Injury
Date Received: May 18, 2011
Date of Event: April 20, 2011
Report Date: June 24, 2011
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

Additional Manufacturer Narrative · 1

THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. NO NEW ISSUES WERE OBSERVED. THIS IS A FINAL REPORT.

Description of Event or Problem · 1

CUSTOMER REPORTED THE TEST DID NOT START ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO IT. SHE FURTHER REPORTED HER "SUGAR WENT SKY HIGH" AND NOTED EXPERIENCING TREMULOUSNESS AND ADDED HER "BODY WASN'T RUNNING RIGHT". IT WAS ADDITIONALLY REPORTED CUSTOMER HAD AN "INFECTION" ON HER HAND. CUSTOMER SELF-PRESENTED TO HER HEALTHCARE PROVIDER AND WAS GIVEN UNSPECIFIED AMOUNTS OF NOVOLOG AND LANTUS INSULIN'S. SHE WAS ALSO INSTRUCTED TO GO TO A LOCAL HEALTHCARE FACILITY, WHERE SHE WAS ADMITTED AND STAYED FOR FOUR DAYS WHILE THEY ADJUSTED HER INSULIN. IT IS UNKNOWN WHAT CUSTOMER WAS DIAGNOSED WITH AT THE HOSPITAL. CUSTOMER ADDITIONALLY SELF-TREATED WITH AN UNKNOWN AMOUNT OF HUMALOG AND NOVOLOG INSULIN'S. 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 FREEDOM LITE	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1019304

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R