BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 700976 · Received April 18, 2006

    Report

    Report Number
    2954323-2006-00200
    Event Type
    Injury
    Date Received
    April 18, 2006
    Date of Event
    April 5, 2006
    Report Date
    April 18, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 05 APR O6 THE CALLER GOT A READING OF 3.1 MMOL/L FROM HER ADC DEVICE. THE CALLER FELT SHAKY, WEAK AND CONFUSED. TO COUNTERACT THE EVENT SHE HAD A BOWL OF FRUIT COCKTAIL. THE PARAMEDICS WERE CALLED AND SHE WAS SENT TO THE HOSPITAL. THE CALLER REPORTED GETTING A READING OF 6.2 MMOL/L BUT DID NOT STATE WHICH METER IT CAME FROM. JER DOCTOR INCREASED HER INSULIN AND DIAGNOSED HER WITH SEVERE HYPERGLYCEMIA. THE REPORTED EVENT IS NOT CONSISTENT WITH THE DIAGNOSIS AND MEDICATION OF THE CALLER'S DOSTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE INC. * 11117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN