FDA Adverse Event Malfunction Summary report: N

OT ULTRALINK METER

MDR report key: 1923493 · Received December 13, 2010

Report

Report Number: 2939301-2010-10707
Event Type: Malfunction
Date Received: December 13, 2010
Date of Event: November 28, 2010
Report Date: November 29, 2010
Manufacturer: LIFESCAN INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PATIENT

Narratives

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

ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 3:00 AM THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF SWEATING AND SHAKING. WHILE SYMPTOMATIC, THE PATIENT OBTAINED AN UNSPECIFIED ERROR MESSAGE ON THE REPORTED METER; SHE DID NOT OBTAIN A BLOOD GLUCOSE READING. AT 5:00 AM THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS BEGAN PRIOR TO THE METER ISSUE AND THERE WAS NO DELAY IN TREATMENT. HOWEVER, AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3045173

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR