BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 308336 · Received December 8, 2000

    Report

    Report Number
    1823260-2000-00255
    Event Type
    Injury
    Date Received
    December 8, 2000
    Date of Event
    November 16, 2000
    Report Date
    November 18, 2000
    Manufacturer
    ROCHE DIAGNOSITCS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AT 6:00PM THE SUSPECT DEVICE WAS USED TO CHECK THE PATIENT'S BLOOD GLUCOSE LEVEL. A RESULT OF 555MG/DL WAS OBTAINED. PT'S FAMILY MEMBER INJECTED 4 UNITS OF REGULAR INSULIN BASED UPON THIS RESULT. AT 6:30PM THE SUSPECT DEVICE READ 270MG/DL. PT BECAME SLEEPY. 911 WAS CALLED. THE EMERGENCY MEDICAL TECHNICIAN'S PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED AN ERROR MESSAGE. THE FAMILY MEMBER CLAIMS A KETO STRIP WAS USED AND THE RESULT FROM IT WAS 240. PT WAS TRANSPORTED TO THE HOSPITAL. THEIR BLOOD GLUCOSE LEVEL FROM A LAB TEST WAS 30MG/DL. PT WAS GIVEN SOMETHING TO EAT AND THEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING TEST STRIPS CFR ROCHE DIAGNOSITCS NA 522520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention