BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1242580 · Received November 21, 2008

    Report

    Report Number
    2954323-2008-02900
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RETURNED, INVESTIGATED AND THE COMPLAINT WAS NOT CONFIRMED. METER POWERED ON WITH BUTTON AND INSERTION OF STRIPS, DID NOT OBSERVE POWER ISSUE WITH STRIP PORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PORT ISSUE WITH HIS METER NOT TURNING ON WITH STRIP INSERTION. HE STATED AS A RESULT HE WAS UNABLE TO TEST, EXPERIENCED HYPOGLYCEMIC SYMPTOMS AND LOST CONSCIOUSNESS. CUSTOMER'S WIFE GAVE HIM JUICE TO HELP REVIVE HIM. THERE WAS NO REPORT OF PARAMEDICS CALLED OR TREATMENT AT A HEALTH CARE FACILITY FOR THIS EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    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 0806027

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention