FREESTYLE FREEDOM

Report

Report Number: 2954323-2010-00999
Event Type: Malfunction
Date Received: July 27, 2010
Date of Event: July 6, 2010
Report Date: August 13, 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 IS NOT CONFIRMED. THE METER POWERED ON WITH BUTTON AND WITH INSERTION OF STRIPS. DID NOT OBSERVE POWER ISSUE WITH STRIP PORT. 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

THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH TOBRAMYCIN (40GM, DAILY, INTRAPERITONEAL (IP)), REFLIN (1GM, DAILY, IP) AND HEPARIN (1000 IU, TID, IP). PD THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH TOBRAMYCIN, REFLIN AND HEPARIN. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED.

Description of Event or Problem · 1

CUSTOMER REPORTED HIS FREESTYLE FREEDOM METER TURNED ON WITH BUTTON PRESSED BUT TURNED OFF UPON TEST STRIP INSERTION. CUSTOMER ALSO REPORTED EXPERIENCING SYMPTOMS OF DIZZINESS, FAINTNESS, LOSS OF CONSCIOUSNESS AND SEIZURE WHILE HE WAS AT WORK. PARAMEDICS WERE CALLED AND THEY TESTED CUSTOMER'S BLOOD GLUCOSE LEVEL. THERE WAS NO REPORT OF SELF-TREATMENT, THIRD PARTY MEDICAL INTERVENTION, 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			0836552

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other