FDA Adverse Event Malfunction Summary report: N

OT ULTRALINK METER

MDR report key: 3123418 · Received May 21, 2013

Report

Report Number: 3008382007-2013-12529
Event Type: Malfunction
Date Received: May 21, 2013
Report Date: April 27, 2013
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K073231
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE METER AND ASSOCIATED TEST STRIPS HAVE BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 (07/02/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/25/2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND; THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING A POWER METER ISSUE. THE METER COULD NOT BE POWERED ON WHEN INSERTING A TEST STRIP AT THE TIME OF TROUBLESHOOTING. THE METER COULD BE POWERED ON WHEN USING THE POWER BUTTON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
225093	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3379366

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR