BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2192686 · Received August 5, 2011

    Report

    Report Number
    3008382007-2011-00155
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. THE 510 (K) # IS K093745. SERIAL NUMBER OF METER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT FROM (B)(6) CONTACTED LFS ALLEGING AN ERROR 4 MESSAGE ON IN ONETOUCH VERIO METER USING TEST STRIPS THAT HE OBTAINED FROM THE PHARMACY. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION OR EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. TEST STRIPS WERE REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED ERROR 4 MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3159867

    Patients

    Seq Age Sex Outcome Treatment
    1