FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 2843362 · Received November 23, 2012

Report

Report Number: 3008382007-2012-06602
Event Type: Malfunction
Date Received: November 23, 2012
Report Date: November 5, 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: 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN IN (B)(6) ALLEGING A ONETOUCH VERIO IQ METER WAS READING INACCURATE RESULTS COMPARED TO THE SAME METER. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE VALUES OF "19.7, 19.9, 14.9MMOL/L" ON THE SAME LFS. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=0.67MMOL/L OR <=15% OBTAINED WITHIN 10 MINUTES OF EACH OTHER. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE SUBJECT METER DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT A SERIOUS INJURY OCCURRED. IN ADDITION THE PATIENT PERFORMED A METER VS. SAME METER COMPARISON WHERE THE CALCULATED DIFFERENCE BETWEEN THE RESULTS MEETS LFS' CRITERIA FOR ACCURACY REPORTING.

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		3357692

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR