BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1004031 · Received February 26, 2008

    Report

    Report Number
    2954323-2008-00915
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN RETURNED FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT SHE OBTAINED LOW READINGS ON HER PRECISION XTRA METER. IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL HAVING LOST CONSCIOUSNESS. THE CUSTOMER OBTAINED READINGS ON THEIR PRECISION XTRA METER OF 294 MG/DL COMPARED TO A LAB READING OF 1764 MG/DL AND A "HI" (A "HI" MESSAGE INDICATES ANY READING GREATER THAN 500 MG/DL) COMPARED TO A LAB METER READING OF 1644 MG/DL WITHIN A 10 MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE "D" ZONE WHICH ARE CONSIDERED TO BE CLINALLY SIGNIFICANT. IT WAS REPORTED THAT THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA CAUSING HYPERGLYCEMIC HYPEROSMOLAR NONKETOTIC STATE AND ALSO SUFFERED HYPOTENSION AND KIDNEY FAILURE CAUSED BY SEVERE DEHYDRATION. IT WAS UNCLEAR WHAT TREATMENT SHE RECEIVED AT THE HOSPITAL. NOTE: PRECISION XTRA LABELING INCLUDES THE FOLLOWING STATEMENT: "TEST RESULTS MAY BE ERRONEOUSLY LOW IF THE PATIENT IS SEVERELY DEHYDRATED, OR SEVERELY HYPOTENSIVE, IN SHOCK OR IN A HYPERGLYCEMIC-HYPEROSMOLAR STATE (WITH OR WITHOUT KETOSIS)." "SIMILAR OBSERVATIONS HAVE BEEN REPORTED IN THE LITERATURE FOR OTHER BLOOD GLUCOSE MONITORING SYSTEMS."

    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 42659

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Hospitalization| R