BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1242588 · Received November 21, 2008

    Report

    Report Number
    2954323-2008-02914
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 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

    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

    THE CUSTOMER REPORTED SHE HAD BEEN EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA WHILE HER METER WAS GIVING HER LOW READINGS (NO SPECIFIC READINGS WERE PROVIDED). SHE ALSO REPORTED HER HUSBAND DROVE HER TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS ADMINISTERED INSULIN INTRAVENOUSLY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 43417

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention