BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 599551 · Received May 4, 2005

    Report

    Report Number
    1823260-2005-01045
    Event Type
    Injury
    Date Received
    May 4, 2005
    Date of Event
    April 13, 2005
    Report Date
    April 17, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE = 418 MG/DL IN THE MORNING. CUSTOMER TOOK 14 UNITS OF INSULIN. CUSTOMER STATED SOME INSULIN LEAKED SO CUSTOMER TOOK ANOTHER 14 UNITS. CUSTOMER WENT TO WORK AND "BOTTOMED OUT". EMERGENCY MEDICAL TECHNICIAN (EMT) WAS CALLED. EMT DEVICE= 41 MG/DL. CUSTOMER WAS GIVEN ORANGE JUICE AND AN IV WITH SUGAR. CUSTOMER WAS TAKEN TO THE HOSP. HOSP =173, 201, & 203 MG/DL. CUSTOMER RECEIVED AN EKG AND WENT HOME THE SAME EVENING. CONTROLS WERE USED BUT VALUES WERE NOT PROVIDED. 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 ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS CORP. NA 522740

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R