FDA Adverse Event Malfunction Summary report: N

OT VERIO PRO METER

MDR report key: 3844549 · Received June 3, 2014

Report

Report Number: 2939301-2014-13129
Event Type: Malfunction
Date Received: June 3, 2014
Report Date: May 26, 2014
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 - 8/1/2014, DEVICE EVALUATION: THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: ERROR 2 MESSAGES OBSERVED IN THE ERROR LOG, BUT THE ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION, HOWEVER A SECONDARY ISSUE WHERE THE METER WAS FOUND TO BE MISSING THE BATTERY. 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 2. 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
323424	OT VERIO PRO METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3433707

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR