BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1790152 · Received July 17, 2007

    Report

    Report Number
    2954323-2007-15201
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    July 20, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER RETURNED PRECISION XTRA WITH SERIAL NUMBER (B)(4) AND TEST STRIPS WITH LOT NUMBER 41662. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED, ALL RESULTS WERE WITHIN RANGE SPECIFICATION, AND NO ERRORS OR OTHER ISSUES WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A DIABETES SPECIALIST NURSE AT (B)(6) CHILDREN'S HOSPITAL REPORTED AN INCIDENT INVOLVING AN (B)(6) GIRL WHO IS ON A BASAL BOLUS INSULIN REGIMEN. THE CHILD HAS 2 PRECISION XTRA BLOOD GLUCOSE METERS, SERIAL NUMBERS (B)(4) AND (B)(4). DURING (B)(4), THE CUSTOMER'S INSULIN DOSAGE WAS 8,6,6 AND 20 INSULIN UNITS. THE CUSTOMER HBA1C WAS 8.4%. IN JANUARY, IT HAD MEASURED 7.6%. AS THE FAMILY HAD REPORTED, THEIR DAUGHTER'S LOW READINGS WERE CAUSING HYPOGLYCEMIA, THE NURSE ASKED THAT THE DOSAGE BE REDUCED TO 4,3,1 AND 15 UNITS OF INSULIN. ON JUNE 26TH, EVEN THOUGH THE CHILD'S BLOOD SUGARS WERE APPARENTLY LOW, SHE COMPLAINED TO THE NURSE OF THIRST AND POLYURIA. THE NURSE VISITED THE FAMILY HOME AND WAS TOLD THAT THE CHILD'S SUGAR LEVELS HAD BECOME HIGH AND THAT KETONES HAD BEEN FOUND IN HER URINE. ANOTHER HBA1C TEST HAD BEEN TAKEN AND WAS FOUND TO BE 10%.

    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 41662

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR