FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2900626 · Received January 7, 2013

Report

Report Number: 3008382007-2013-00208
Event Type: Malfunction
Date Received: January 7, 2013
Report Date: December 13, 2012
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: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 (08/14/2013)-PRODUCT EVALUATION: THE ANALYSIS OF THE METER WAS COMPLETED ON 08/07/2013 BY LIFESCAN PRODUCT ANALYSIS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE MET ALL SPECIFICATIONS FOR TESTING AND NO ISSUES WERE OBSERVED DURING INVESTIGATION. 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) 2012, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS COMPARED TO ANOTHER METER. THE PATIENT ALLEGED READINGS OF "9.3MMOL/L" ON THE LFS METER COMPARED TO "7.1MMOL/L" ON ANOTHER UNKNOWN METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY 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
6924	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3372942

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR