BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1242582 · Received November 21, 2008

    Report

    Report Number
    2954323-2008-02898
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER'S NURSE REPORTED THE CUSTOMER'S METER DID NOT TURN ON AFTER THE TEST STRIP WAS INSERTED INTO THE PORT. AS A RESULT, THE CUSTOMER REPORTEDLY EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND LOSE CONSCIOUSNESS. IT WAS ALSO REPORTED THE CUSTOMER WAS ABLE TO OBTAIN A BLOOD GLUCOSE READING OF 44 MG/DL AFTER THEY RECOVERED CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO DIABETES RELATED MEDICATIONS WERE REPORTEDLY TAKEN AT THE TIME OF THE EVENT. THE CUSTOMER'S NURSE REPORTED THE CUSTOMER DRANK ORANGE JUICE TO ALLEVIATE THE SYMPTOMS. TWO DAYS AFTER THE EVENT, THE CUSTOMER'S NURSE REPORTED THE CUSTOMER WENT TO A HOSPITAL, BUT THERE WAS NO REPORT OF DIAGNOSIS OR TREATMENT FOR SEVERE HYPO- OR HYPERGLYCEMIA. AT THE HOSPITAL, THE CUSTOMER REPORTEDLY RECEIVED FLUIDS DUE TO BEING DEHYDRATED. 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 NA 0634717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention