FDA Adverse Event Malfunction Summary report: N

OT ULTRALINK METER

MDR report key: 2061707 · Received April 18, 2011

Report

Report Number: 2939301-2011-03174
Event Type: Malfunction
Date Received: April 18, 2011
Report Date: March 28, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K)# IS K073231.

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 OTHER MESSAGE WAS NOT RESOLVED WITH TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3093953

Patients

Seq	Age	Sex	Outcome	Treatment
1