FDA Adverse Event Malfunction Summary report: N

OT ULTRALINK METER

MDR report key: 1874594 · Received October 19, 2010

Report

Report Number: 2939301-2010-09216
Event Type: Malfunction
Date Received: October 19, 2010
Report Date: October 14, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

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.

Additional Manufacturer Narrative · 1

(B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

Description of Event or Problem · 1

REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 263 MG/DL AND 91 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

Description of Event or Problem · 1

THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON WITH STRIP INSERTION OR PRESSING BUTTONS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.		3044317

Patients

Seq	Age	Sex	Outcome	Treatment
1	14 YR