BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 805464 · Received January 11, 2007

    Report

    Report Number
    1826988-2007-00032
    Event Type
    Injury
    Date Received
    January 11, 2007
    Date of Event
    December 14, 2006
    Report Date
    December 14, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 19 MMOL/L. HE RETESTED WITHIN A FEW MINUTES AND RECEIVED READINGS OF 12 AND 10 MMOL/L. HE THEN TOOK 20 UNITS OF INSULIN AND ATTEMPTED TO LEAVE THE HOUSE. WHILE BACKING OUT OF HIS DRIVEWAY, HE BLACKED OUT AND HIT A TREE. WHEN HE REGAINED CONSCIOUSNESS ABOUT AN HOUR LATER, HE WAS DRENCHED IN SWEAT. HE ATE SOMETHING SWEET TO RAISE HIS GLUCOSE LEVEL, BUT DID NOT REQUIRE MEDICAL ATTENTION. THE METER AND TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT PRODUCTS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 BASIC BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3903E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR