FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2971338 · Received February 21, 2013

Report

Report Number: 3008382007-2013-03399
Event Type: Malfunction
Date Received: February 21, 2013
Report Date: February 14, 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: SP
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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) SPAIN ALLEGING HIS ONETOUCH VERIO IQ METER WOULD NOT POWER ON DUE TO A BATTERY CHARGE ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT WAS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL TREATMENT DUE TO THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. THE PATIENT ADVISED THE SUBJECT METER WAS PLUGGED INTO A POWER OUTLET FOR A COUPLE HOURS BEFORE "EXPLODING." REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
75917	OT VERIO IQ METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3388053

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR