BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1161247 · Received September 11, 2008

    Report

    Report Number
    2954323-2008-02542
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR METER WOULD NOT TURN ON WITH STRIP INSERTION AND THEY WERE UNABLE TO TEST. AS A RESULT, THEY STATED THEY EXPERIENCED HYPERGLYCEMIC SYMPTOMS, HEADACHES, AND EXTREME TIREDNESS. THEY WERE SEEN BY THEIR LOCAL DOCTOR, DIAGNOSED WITH HYPERGLYCEMIA AND THEIR INSULIN DOSAGES WERE ADJUSTED AND A NEW MEDICATION WAS PRESCRIBED. THERE WAS NO REPORT OF DEATH OR PERMANENT. IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0724031

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention