FREESTYLE LITE

MDR report key: 1862249 · Received October 8, 2010

Report

Report Number: 2954323-2010-01405
Event Type: Injury
Date Received: October 8, 2010
Date of Event: September 10, 2010
Report Date: December 15, 2010
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

Additional Manufacturer Narrative · 1

AS THE REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(6) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THIS IS A FINAL REPORT.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT ON (B)6) 2010 SHE RECEIVED A READING OF 120 MG/DL ON HER FREESTYLE LITE BLOOD GLUCOSE METER, THE FIRST TIME SHE ATTEMPTED TO USE IT AND SUBSEQUENTLY EXPERIENCED A SEIZURE THAT RESULTED IN A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY WHERE A READING OF 29 MG/DL WAS RECEIVED ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH AN UNKNOWN "LIQUID". MULTIPLE, UNSUCCESSFUL, ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO GATHER ADDITIONAL INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE ERROR 2 WAS NOT RESOLVED WITH TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FREESTYLE LITE	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1013316

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R