FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2780259 · Received October 10, 2012

Report

Report Number: 3008382007-2012-04913
Event Type: Malfunction
Date Received: October 10, 2012
Report Date: September 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: VA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

ON (B)(4) 2012, DEVICE EVALUATION: THE TEST STRIPS INVOLVED IN THIS COMPLAINT WERE RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED BUT THE TEST STRIP VIAL LABEL IS TORN IN THE NON CRITICAL PRINT AREA. 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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH VERIO IQ METER WAS NOT POWERING ON WHEN A TEST STRIP WAS INSERTED. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE TEST STRIPS WERE RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED BUT THE TEST STRIP VIAL LABEL IS TORN IN THE NON CRITICAL PRINT AREA. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3302196

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR