BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1803091 · Received September 26, 2007

    Report

    Report Number
    2954323-2007-17994
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    August 21, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH HIS PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER. HE REPORTED "EXPERIENCING SYMPTOMS OF LOW BLOOD SUGAR" AS FOLLOWS: "BLURRED VISION, LIGHTHEADNESS AND COULD NOT MAKE SHARP DECISIONS". BECAUSE OF THOSE SYMPTOMS, THE CUSTOMER REPORTED GOING TO THE DOCTOR AT THE (B)(6) CLINIC AND DURING THE VISIT, A BLOOD TEST WAS PERFORMED AND COMPARED TO THE METER READING. THE TESTS WERE PERFORMED WITHIN A TEN MIN TIMEFRAME. THE METER RESULT OBTAINED WAS 69 MG/DL WHILE THE LAB RESULT WAS 110 MG/DL. WHEN PLOTTING THE READINGS ON A PARKES ERROR GRID, THE METER RESULT FELL IN THE "C" ZONE. THE "C" ZONE RESULT SHOWS THE DIFFERENCE IN READINGS TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 41493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other