ONE TOUCH ULTRALINK METER

Report

• Report Number: 2939301-2008-01835
• Event Type: Malfunction
• Date Received: August 12, 2008
• Report Date: July 25, 2008
• Manufacturer: LIFESCAN, INC.
• Product Code: NBW
• PMA / PMN Number: NA
• Removal / Correction Number: NA
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: MA, US
• Reporter Occupation: LAY USER/PATIENT

Narratives

Description of Event or Problem · 1

THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS HAVING THE FOLLOWING POWER RELATED ISSUE: STRIP INSERTION ISSUE, WHICH WAS UNRESOLVED WITH TROUBLESHOOTING. THE PATIENT MENTIONED ABOUT FEELING SWEATY SOMETIME BEFORE THE ALLEGED ISSUE BEGAN, THEREFORE LFS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONE TOUCH ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Sweating

Product problems · 1

• Difficult to Insert

Source type · 1

• Consumer

Type of report · 1

• Initial submission