FDA Adverse Event Malfunction Summary report: N

OT VERIO2 METER

MDR report key: 4914595 · Received July 15, 2015

Report

Report Number: 2939301-2015-29495
Event Type: Malfunction
Date Received: July 15, 2015
Report Date: July 2, 2015
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: FR
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 THE LAY USER/PATIENT¿S CONTROL SOLUTION AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE CONTROL SOLUTION AND 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) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE HIGH CONTROL SOLUTION RESULTS. THE REPORTER CLAIMED OBTAINING CONTROL SOLUTION WHICH FELL ABOVE THE SPECIFIED CONTROL SOLUTION RANGE PRINTED ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY CONTROL 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
458415	OT VERIO2 METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3794324

Patients

Seq	Age	Sex	Outcome	Treatment
1