BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 1051754 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00547
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 27, 2008
    Report Date
    April 27, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER PASSED OUT WHILE DRIVING. HIS BLOOD GLUCOSE WAS TESTED AT 46 MG/DL. THE ADVOCATE GAVE THE CUSTOMER A PIECE OF CANDY AND SOME JUICE WHEN HE ARRIVED HOME. PARAMEDICS WERE CALLED. THEY TESTED THE CUSTOMER'S GLUCOSE AT 51MG/DL. THE CUSTOMER WAS NOT TAKEN TO THE HOSPITAL. THE ADVOCATE DID NOT PROVIDE ANY MORE INFORMATION ABOUT THE INCIDENT. TROUBLESHOOTING OF THE CUSTOMER'S BREEZE2 SYSTEM WAS NOT POSSIBLE BECAUSE HIS CONTROL TEST SOLUTION WAS EXPIRED. THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 50 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3627AC BT3629TA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention