FDA Adverse Event Malfunction Summary report: N

OT VERIO2 METER

MDR report key: 3853752 · Received June 6, 2014

Report

Report Number: 2939301-2014-13671
Event Type: Malfunction
Date Received: June 6, 2014
Report Date: May 28, 2014
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K131363
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 2 ¿ (02/28/2015). THE PATIENT¿S METER HAS BEEN RETURNED ON 7/1/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 2/18/2015 WITH THE FOLLOWING FINDINGS:NO ERROR MESSAGE IS OBSERVED IN THE ERROR LOG, AND ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION. 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

FOLLOW-UP # 1 ¿ (07/16/2014).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 6/12/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/4/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE 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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR UNKNOWN. 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
331941	OT VERIO2 METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

Patients

Seq	Age	Sex	Outcome	Treatment
1