FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2951292 · Received February 8, 2013

Report

Report Number: 3008382007-2013-02608
Event Type: Malfunction
Date Received: February 8, 2013
Report Date: January 18, 2013
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K110637
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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

(B)(4): THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG, HOWEVER, NO MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTING. PA WAS UNABLE TO REPRODUCE THE COMPLAINT. 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

THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. LFS WILL EVALUATE IT AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

ON (B)(4) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR 4. 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
53480	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3390288

Patients

Seq	Age	Sex	Outcome	Treatment
1