BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2379926 · Received December 16, 2011

    Report

    Report Number
    3008382007-2011-01040
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Report Date
    November 21, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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)(6) ALLEGING THAT TEST STRIPS WERE MISSING FROM THE TEST STRIP VIALS. THE REPORTED ISSUE WAS RESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WERE NO ALLEGATIONS OF HARM OF INJURY. REPLACEMENT PRODUCTS WERE SENT TO 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 3168125

    Patients

    Seq Age Sex Outcome Treatment
    1