FDA Adverse Event Malfunction Summary report: N

OT VERIO METER

MDR report key: 2233848 · Received September 4, 2011

Report

Report Number: 3008382007-2011-00338
Event Type: Malfunction
Date Received: September 4, 2011
Report Date: August 9, 2011
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4), 2011 THE TEST STRIPS WERE TESTED AND THE ALLEGED ISSUE WAS CONFIRMED WHEN TESTING WITH CONTROL SOLUTION DURING INVESTIGATION. ON (B)(4), 2011 THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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

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; 510K#: K093745.

Description of Event or Problem · 1

THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO METER WAS GIVING THE ERROR 4 ERROR MESSAGE; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT, AND THE TEST STRIPS COMPLETELY DREW IN THE BLOOD SAMPLE. THE PATIENT SUFFERED NO INJURY DUE TO THIS ISSUE. THE ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT VERIO METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3158810

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR