BEUDAMED
    FDA Adverse Event Summary report: N

    FREESTYLE LIGHT

    MDR report key: 3070507 · Received April 18, 2013

    Report

    Report Number
    MW5029851
    Date Received
    April 18, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ABBOTT DIABETES
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES HE HAS RECEIVED INACCURATE GLUCOSE READINGS FROM 6 DIFFERENT FREESTYLE LIGHT GLUCOSE MONITORS IN THE PAST 8 YEARS. HE REPORTS THIS MORNING HIS GLUCOSE READINGS WERE 122 AND 154 AT THE SAME TIME ON TWO DIFFERENT FREESTYLE LIGHT GLUCOSE MONITORS. CALLER WENT TO THE DOCTOR AND WAS PRESCRIBED A NEW GLUCOSE MONITOR FROM JOHNSON AND JOHNSON. CALLER RECHECKED HIS GLUCOSE LEVEL WITH ALL THREE DEVICES THE TWO FREESTYLE LIGHT GLUCOSE MONITORS READ 138 AND 156 WHILE THE NEW MONITOR READ 266. CALLER STATES HE FELT LIKE HE WAS GOING TO PASS OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167468 FREESTYLE LIGHT GLUCOSE MONITOR NBW ABBOTT DIABETES
    167469 FREESTYLE LIGHT GLUCOSE MONITOR NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR