BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1241260 · Received November 18, 2008

    Report

    Report Number
    2954323-2008-02886
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    September 3, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER'S FRIEND REPORTED THAT THE CUSTOMER EXPERIENCED A BATTERY ISSUE WITH THEIR METER AND IN 2008, SHE BEGAN EXPERIENCING VISION PROBLEMS AND LOST CONSCIOUSNESS. CUSTOMER WAS TAKEN TO A LOCAL HOSPITAL AND DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER WAS ALSO REPORTEDLY TREATED WITH INSULIN, ASPIRIN AND SUGAR WATER WHICH TOGETHER ARE INCONSISTENT WITH THE DIAGNOSIS. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO CLARIFY THE PRODUCT ISSUE AND HOW IT RELATED TO THE MEDICAL EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    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 NI 43146

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention