BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1000026 · Received February 7, 2008

    Report

    Report Number
    2954323-2008-00748
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    December 31, 2007
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND INVESTIGATED, AND THE COMPLAINT WAS NOT CONFIRMED. NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION, AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY OBTAINED HIGH READINGS ON THEIR PRECISION XTRA METER. IT WAS REPORTED THAT THE CUSTOMER OBTAINED READINGS OF 6MMOL/L AND 4MMOL/L ON THEIR PRECISION XTRA METER COMPARED TO 4MMOL/L AND 2MMOL/L ON A FREESTYLE FLASH METER. ALTHOUGH THE METER TO METER READINGS ARE NOT VALID COMPARISONS, IT WAS REPORTED THAT DUE TO THE HIGH READINGS (6MMOL/L AND 4MMOL/L), THE CUSTOMER TOOK MORE INSULIN AND AS A RESULT BECAME UNCONSCIOUS. THE CUSTOMER'S WIFE CALLED AN AMBULANCE AND THE CUSTOMER WAS TAKEN TO A HOSPITAL. THE CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND WAS TREATED WITH GLUCOSE PRIOR TO BEING DISCHARGED TWO DAYS LATER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    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 80139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other