BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1032509 · Received April 21, 2008

    Report

    Report Number
    2954323-2008-01539
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 2, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER HAS BEEN RETURNED TO THE LAB AND NO READING ISSUES NOR BLANK SCREEN WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPEC AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. METER DID POWER ON WITH BUTTON DEPRESSION OR INSERTION OF STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOT BEING ABLE TO TEST HER BLOOD GLUCOSE DUE TO A BLANK SCREEN ON THEIR FREESTYLE FREEDOM METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA, LOSS OF CONSCIOUSNESS AND GRAND MAL SEIZURE. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH SUGAR VIA AN IV. CUSTOMER WAS THEN TRANSPORTED TO MEDICAL CENTER WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH POTASSIUM THROUGH HER IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NA 0718019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R