BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2944334 · Received February 5, 2013

    Report

    Report Number
    3008382007-2013-02307
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 25, 2013
    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

    LOT # OF THE TEST STRIPS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS ALLEGING AN UNKNOWN ISSUE WITH THE VERIO PRO METER. THE PATIENT WAS UNABLE/UNWILLING TO PROVIDE ANY FURTHER DETAILS ABOUT THE ALLEGED ISSUE. PATIENT DID NOT REPORT ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED AN UNSPECIFIED ISSUE WITH THE VERIO PRO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48639 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR