BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 4130485 · Received September 30, 2014

    Report

    Report Number
    2954323-2014-00998
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 3, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE EXACT DATE OF EVENT IS UNKNOWN. THE DATE ENTERED, IS BASED ON CUSTOMER'S APPROXIMATION OF EVENT OCCURRENCE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST USING HER ADC BLOOD GLUCOSE METER, STATING SHE COULD NOT OBTAIN A PROPER BLOOD SAMPLE WHEN USING THE LANCING DEVICE AND HER METER WOULD NOT PROVIDE A READING AFTER A BLOOD SAMPLE WAS APPLIED. CUSTOMER ADDITIONALLY REPORTED THAT APPROXIMATELY ONE MONTH PRIOR TO CONTACTING ADC SHE "WAS AT HER HOUSE AND (SHE) FELT DIZZY, INCOHERENT" AND HER FRIENDS COULD NOT "FEEL (HER) PULSE". CUSTOMER REPORTED A FRIEND CALLED THE PARAMEDICS AND UPON THEIR ARRIVAL SHE WAS ADMINISTERED AN UNSPECIFIED ORAL MEDICATION AND TRANSPORTED TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER REPORTED NO TREATMENT WAS RENDERED AT THIS HOSPITAL BUT SHE WAS REPORTEDLY HOSPITALIZED FOR TWO DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608963 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1370542

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R