BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISON XTRA

    MDR report key: 1117845 · Received August 14, 2008

    Report

    Report Number
    2954323-2008-02411
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT, NO FURTHER INVESTIGATION IS REQUIRED. COMPLAINTS ARE MONITORED THROUGH TRENDING, AND PERIODIC FAILURE MODE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DELIVERY ISSUE WITH HIS PRECISION XTRA METER AND NOT ABLE TO TEST HIS BLOOD GLUCOSE FOR ALMOST A YEAR. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF DRY MOUTH, BLURRED VISION AND SLEEPINESS. CUSTOMER REPORTED GOING TO HEALTH CENTER WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND BEING TREATED WITH INSULIN AND INTRAVENOUS SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISON XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC., USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization