FDA Adverse Event Malfunction Summary report: N

OT VERIO PRO PLUS METER

MDR report key: 3901157 · Received June 30, 2014

Report

Report Number: 2939301-2014-15712
Event Type: Malfunction
Date Received: June 30, 2014
Report Date: June 13, 2014
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 ¿ (08/27/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/1/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/15/2014 WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE INCORRECT PARAMETERS IN SETTING. 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 INACCURATE CONTROL ERRATIC. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE SUBJECT PRODUCTS WERE REQUESTED BACK FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379927	OT VERIO PRO PLUS METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3578697

Patients

Seq	Age	Sex	Outcome	Treatment
1