BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT ACT/SOFT-SENSE

    MDR report key: 1080175 · Received July 21, 2008

    Report

    Report Number
    2954323-2008-02290
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING "EXTREMELY HIGH" READINGS ON HER SOFTAC METER AND EXPERIENCING HEADACHES, DIZZINESS, DIAPHORESIS, "BANGING INTO THE WALLS AND FOAMING FROM THE MOUTH". SHE DECLINED HAVING A SEIZURE BUT REPORTED LOSING CONSCIOUSNESS. THE CUSTOMER WAS TRANSPORTED TO A LOCAL HOSPITAL VIA PARAMEDICS AND STAYED INPATIENT FOR 5-DAY OBSERVATION. THE CUSTOMER REPORTED BEING DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH UNKNOWN INTRAVENOUS SOLUTION AND SUGAR WATER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT ACT/SOFT-SENSE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NI 30647

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention