FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 3941908 · Received July 17, 2014

Report

Report Number: 2939301-2014-17712
Event Type: Malfunction
Date Received: July 17, 2014
Report Date: July 7, 2014
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: NJ, US
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.

Description of Event or Problem · 1

ON (B)(6), 2014 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING THE ERROR 2 ERROR MESSAGE DURING TESTING. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6), 2014 THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 DURING TESTING; SHE DID NOT OBTAIN A BLOOD GLUCOSE READING. THE PATIENT NOTED THIS WAS A NEW, OUT-OF-THE-BOX, METER. THE PATIENT TOOK THE ACTION OF CONSUMING LESS FOOD AND DRINK. THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. ON (B)(6), 2014 THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS TESTED TO BE 121 MG/DL ON ANOTHER METER. THE PATIENT RECEIVED NO TREATMENT OR MEDICAL ATTENTION. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT SUFFERED NO SYMPTOMS AND RECEIVED NO MEDICAL ATTENTION. HOWEVER AS THE ISSUE WAS NOT RESOLVED THIS COMPLAINT IS BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
418262	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3600783

Patients

Seq	Age	Sex	Outcome	Treatment
1