BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2389622 · Received December 27, 2011

    Report

    Report Number
    3008382007-2011-01184
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Report Date
    December 7, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) IS K093745.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THERE WAS AN OPEN VIAL OF TEST STRIPS IN THE TEST STRIP BOX. THE REPORTED ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WERE NO ALLEGATIONS OF HARM OF INJURY. REPLACEMENT PRODUCT(S) WERE SENT TO THE PATIENT. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN DISCARDED BY THE PATIENT.

    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 3218213

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR