BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1670308 · Received April 29, 2010

    Report

    Report Number
    2954323-2010-00594
    Event Type
    Injury
    Date Received
    April 29, 2010
    Date of Event
    April 4, 2010
    Report Date
    April 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HER PRECISION XTRA BLOOD GLUCOSE METER WOULD TURN ON WITH THE BUTTON, BUT NOT WHEN A TEST STRIP WAS INSERTED INTO THE PORT. AS A RESULT, THE CUSTOMER REPORTED SHE WAS UNABLE TO TEST AND TOOK INSULIN. THE CUSTOMER REPORTEDLY EXPERIENCED THIRST, BLURRED VISION, AND FAINTNESS ON (B) (6) 2010, AND THEN ON (B) (6) 2010, SHE EXPERIENCED BLURRED VISION AND FELT "OFF BALANCE". THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS. IT WAS ADDITIONALLY REPORTED THAT ON (B) (6) 2010, THE CUSTOMER WENT TO A HOSPITAL WHERE SHE WAS ADMITTED, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND INTRAVENOUS FLUIDS. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 44668

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R