BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1153234 · Received September 4, 2008

    Report

    Report Number
    1823260-2008-06699
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER FELT DIZZY AND SHAKY (HYPOGLYCEMIC) AND COULD NOT PRIME THE ACCU-CHEK MULTICLIX LANCET DEVICE. AS A RESULT, THE CUSTOMER COULD NOT OBTAIN A BLOOD GLUCOSE TEST. THE PARAMEDICS WERE CALLED 30 MINUTES LATER AND ARRIVED IN 3 MINUTES. THE PARAMEDICS DID NOT TEST OR TREAT THE CUSTOMER. THEY TRANSPORTED HIM TO THE HOSPITAL. HIS INITIAL BG WAS 27MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS TREATED WITH 4 JELLY SANDWICHES (HYPOGLYCEMIA) AND 5 BAGS OF POTASSIUM(LOW POTASSIUM). NEW LANCET DEVICE WITH LANCETS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R LEVEMIR 1 YEAR| HMALOG 1 YEAR