BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK

    MDR report key: 602033 · Received May 11, 2005

    Report

    Report Number
    1823260-2005-01208
    Event Type
    Injury
    Date Received
    May 11, 2005
    Date of Event
    April 5, 2005
    Report Date
    May 4, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE WAS GIVING LOW READINGS. AT 12 PM, DEVICE = 43 MG/DL. CUSTOMER'S DAUGHTER GAVE CUSTOMER ORANGE JUICE AND A MUFFIN. CUSTOMER FELT DIZZY AND DID NOT FEEL WELL. DAUGHTER DROVE CUSTOMER TO THE DOCTOR OPFFICE. DOCTOR DEVICE = 315 MG/DL AND LAB = 325 MG/DL. DOCTOR ADVISED CUSTOMER TO TAKE A PILL OF CUSTOMER'S DIABETIC MEDICATIONS. CUSTOMER TOOK PILL AND STARTED TO FEEL BUTTER. AT 1:30 PM, DOCTOR DEVICE = 150 MG/DL. NO CONTROLS WERE USED. A REQUEST WAS MADE FOR RETURN PRODUCT AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention