FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2970905 · Received February 21, 2013

Report

Report Number: 3008382007-2013-03343
Event Type: Malfunction
Date Received: February 21, 2013
Report Date: January 25, 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: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP (4/15/2013)-DEVICE EVALUATION: THE METER, USB CABLE, AND AC ADAPTER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER, USB CABLE, AND AC ADAPTER HAVE 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. DEVICE RETURNED TO MFG DATE: METER-(B)(6) 2013, USB CABLE- (B)(6) 2013, AC ADAPTER- (B)(6) 2013.

Additional Manufacturer Narrative · 1

THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING DOES NOT TURN ON. 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
77226	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3319548

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR