BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2196004 · Received August 8, 2011

    Report

    Report Number
    3008382007-2011-00178
    Event Type
    Malfunction
    Date Received
    August 8, 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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K093745.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING AN ISSUE WITH THE TEST STRIPS; HOWEVER, WAS UNABLE TO PROVIDE SPECIFICS. THE REPORTED ISSUE WAS NOT RESOLVED WITH CUSTOMER SERVICE TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. THE REPORTER WAS ADVISED TO CONTACT CUSTOMER SERVICE BACK WITH MORE DETAILS. AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BASED ON THE PROVIDED INFORMATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR