BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2386480 · Received December 22, 2011

    Report

    Report Number
    3008382007-2011-01142
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Report Date
    December 1, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THAT THE SUBJECT METER WAS GIVING ERRATIC METER READINGS. THE METER REPORTEDLY READ "16.0 AND 7.4 MMOL/L" WITHIN 20 MINUTES OF EACH OTHER WITH THE SAME APPROVED SAMPLE SOURCE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDED LIFESCAN'S CRITERIA FOR ACCURACY. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3169159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR