FREESTYLE FREEDOM

Report

Report Number: 2954323-2010-01266
Event Type: Injury
Date Received: September 13, 2010
Date of Event: August 19, 2010
Report Date: October 18, 2010
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A BASAL/BOLUS INFUSOR DEVICE RUPTURED DURING FILLING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem · 1

CUSTOMER'S NEIGHBOR REPORTED CUSTOMER RECEIVED A READING OF 343 MG/DL FROM HER FREESTYLE FREEDOM METER WHICH WAS HIGHER WHEN COMPARED TO A HCP METER (40 MG/DL). CUSTOMER'S NEIGHBOR ALSO REPORTED CUSTOMER MAY HAVE TAKEN EXTRA DOSAGE OF HER INSULIN MEDICATION ACCORDING TO THE READING RECEIVED. CUSTOMER'S NEIGHBOR FURTHER REPORTED CUSTOMER WAS FOUND UNCONSCIOUS AND HAVING A SEIZURE AT CUSTOMER'S HOME. PARAMEDICS WERE CALLED AND THEY TREATED CUSTOMER WITH IV AND GLUCOSE GEL. CUSTOMER WAS THEN TAKEN TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA BUT THE TREATMENT IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FREESTYLE FREEDOM	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1014420

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R