BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2223432 · Received August 25, 2011

    Report

    Report Number
    3008382007-2011-00250
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 26, 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

    .

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THERE WERE 25 TEST STRIPS IN THE ONETOUCH VERIO TEST STRIP VIAL EVEN THOUGH THE LABELING SAYS IT SHOULD CONTAIN 10 TEST STRIPS. THE REPORTED ISSUE WAS NOT RESOLVED WITH CUSTOMER SERVICE TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    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 3123230

    Patients

    Seq Age Sex Outcome Treatment
    1