BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1414441 · Received July 13, 2009

    Report

    Report Number
    2954323-2009-00996
    Event Type
    Injury
    Date Received
    July 13, 2009
    Date of Event
    June 15, 2009
    Report Date
    July 13, 2009
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. DURING THE COURSE OF TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS DISCOVERED THAT THE CUSTOMER WAS USING EXPIRED TEST STRIPS AND THE TEST STRIPS EXPIRED ON 05/31/2009. PRECISION METERS ARE DESIGNED TO DISPLAY AN ERROR MESSAGE WHEN THE TEST STRIPS ARE EXPIRED. IN ADDITION, THE CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS AND WAS ABLE TO CALIBRATE THEIR METER TO THE NEW STRIP LOT CODE. THIS PRODUCT ISSUE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO PRODUCT INVESTIGATION IS NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE ABOUT TWO AND A HALF WEEKS AGO ON THEIR PRECISION XTRA METER AND EXPERIENCED SWEATINESS, LOSS OF VISION AND FLANK PAIN. THE CUSTOMER WAS SEEN AT A HEALTH CARE FACILITY, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN. 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC., USA NA 43006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention