BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1032641 · Received April 21, 2008

    Report

    Report Number
    2954323-2008-01543
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 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 PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A F/U REPORT WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE ON HIS FREESTYLE FLASH METER WAS UNABLE TO TEST AND EXPERIENCED HYPOGLYCEMIC SYMPTOMS. HE STATED HE WOKE UP IN "ALMOST DIABETIC SHOCK" AND CALLED PARAMEDICS. PARAMEDICS TRANSFERRED THE CUSTOMER TO A LOCAL HOSP WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH GLUCOSE TABLETS AND WATER. THE CUSTOMER ALSO REPORTED ADD'L MEDICAL TREATMENT RENDERED TO HIM,HOWEVER, HE DOES NOT RECALL WHAT THE TREATMENT WAS. 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 0722202

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other