BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1802286 · Received October 5, 2007

    Report

    Report Number
    2954323-2007-18855
    Event Type
    Malfunction
    Date Received
    October 5, 2007
    Date of Event
    September 5, 2007
    Report Date
    October 5, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE COMPLETED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER TESTED BLOOD GLUCOSE AND RECEIVED A READING OF 184 MG/DL. CUSTOMER TOOK INSULIN SHOT AND ATE DINNER. ABOUT AN HOUR AND FIFTEEN MINUTES LATER, CUSTOMER WENT INTO DIABETIC SHOCK. PARAMEDICS WERE CALLED AND CUSTOMER WAS TRANSPORTED TO (B)(6) HOSPITAL WHERE A GLUCOSE READING OF 47 MG/DL WAS OBTAINED. CUSTOMER REPORTED SYMPTOMS OF BEING "VERY LETHARGIC AND UNAWARE OF HER SURROUNDINGS." SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 41830

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization