FDA Adverse Event Malfunction Summary report: N

OT VERIO PRO METER

MDR report key: 2801947 · Received October 23, 2012

Report

Report Number: 3008382007-2012-05449
Event Type: Malfunction
Date Received: October 23, 2012
Report Date: October 3, 2012
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED AND FAILED TESTING DUE TO AN ERROR 4 BEING OBSERVED. A SECONDARY ISSUE WAS ALSO NOTED WHERE PA IDENTIFIED EXTRA TEST STRIPS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

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'S PHARMACIST CONTACTED LIFESCAN FROM (B)(6), ALLEGING AN ERROR 4 MESSAGE ISSUE WITH THE ONE TOUCH VERIO PRO METER. THE PATIENT'S PHARMACIST DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S PHARMACIST CLAIMED THE METER HAD AN ERROR 4 MESSAGE ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S PHARMACIST 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 PRO METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3265637

Patients

Seq	Age	Sex	Outcome	Treatment
1