BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1152824 · Received September 3, 2008

    Report

    Report Number
    2954323-2008-02486
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    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 PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE F/U REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER'S FAMILY MEMBER CALLED IN 2008 REPORTING THE CUSTOMER LOST CONSCIOUSNESS AND HAD A SEIZURE ON THE PREVIOUS MONTH. PARAMEDICS WERE CALLED AND AFTER CHECKING HIS BLOOD GLUCOSE GAVE HIM 2 TUBES OF GLUCOSE AND THEN CUSTOMER ATE SOME FOOD TO BRING HIS SUGAR UP. THE CUSTOMER WAS NOT TRANSPORTED TO A HOSP AND NO TREATMENT OUTSIDE OF THE NORMAL DIABETIC'S REGIME WAS ADMINISTERED. THEY ALSO REPORTED RECEIVING READINGS OF 330, 229 AND 165 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO A "B" ZONE SHOWING DIFFERENCE IN VALUES BEING CLINICALLY INSIGNIFICANT. HOWEVER, IT IS UNCLEAR WHETHER THESE READINGS WERE OBTAINED AT THE TIME OF THE MEDICAL EVENT, WHICH OCCURRED ON THAT DAY. 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 SYS NBW ABBOTT DIABETES CARE INC, USA NI 42665

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention