BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1820178 · Received September 14, 2007

    Report

    Report Number
    2954323-2007-17316
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 15, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT METER HAS BEEN SENT TO CUSTOMER. DUE TO THE NATURE OF THE MEDICAL EVENT A REPORT IS BEING FILED. GIVEN THIS PERTAINS TO A DELIVERY PROBLEM, THE METER WILL NOT BE RETURNED FOR AN INVESTIGATION. THEREFORE, THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DUE TO A DELIVERY DELAY OF A REPLACEMENT METER HE DID NOT TEST HIS BLOOD GLUCOSE, EXPERIENCED DIZZINESS AND PASSED OUT ON (B)(6) 2007. HE DID NOT SEEK THIRD PARTY MEDICAL INTERVENTION AND NO DIAGNOSIS IS DOCUMENTED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other