BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 530083 · Received June 17, 2004

    Report

    Report Number
    2954323-2004-00080
    Event Type
    Injury
    Date Received
    June 17, 2004
    Date of Event
    May 29, 2004
    Report Date
    June 17, 2004
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY MEMBER REPORTING TESTING PT WITH THE FREESTYLE METER ON THE FINGER GETTING A RESULT OF 496 MG/DL. THE FAMILY MEMBER TOOK THE PT TO THE DR'S OFFICE WHERE THEY WERE TESTED WITH THEIR UNKNOWN BRAND METER WITH A RESULT OF 55 MG/DL. THE DOCTOR ADVISED TO GO TO THE ER. ANOTHER FREESTYLE TEST WAS PERFORMED BEFORE GOING TO THE ER WITH A RESULT OF 486 MG/DL. AT THE ER, AN UNKNOWN BRAND METER TESTED THE PT AT 55 MG/DL AND THEY WERE TREATED WITH APPLE JUICE AND ICEPOPS. LAB TESTS WERE ALSO PERFORMED BUT THE FAMILY MEMBER OOES NOT REMEMBER THE RESULT OF THE LAB TESTS. THE REPORTED FREESTYLE READINGS OF 496 AND 486 MG/DL WERE NOT CONSISTENT WITH THE TREATMENT THE CUSTOMER RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. NA 0327647

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R