BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE GTS

    MDR report key: 625877 · Received August 10, 2005

    Report

    Report Number
    1823260-2005-02330
    Event Type
    Injury
    Date Received
    August 10, 2005
    Date of Event
    July 22, 2005
    Report Date
    July 23, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THT THE DEVICE HAD GENERATED SEVERAL BLOOD GLUCOSE RESULTS (222, 224, 515, 516, 322, 316, 188, 266 AND 389MG/DL). TESTING VARIOUS PATIENTS, WHICH WERE HIGHER THAN ANTICIPATED. REPORTER INDICATED THAT TWO PATIENTS WERE TREATED FOR ELEVATED BLOOD GLUCOSE, AND AS A RESULT, THEIR BLOOD GLUCOSE DROPPED INTO THE 40MG/DL RANGE. REPORTER STATED, FOLLOWINGTHE UNUSUAL RESULTS, CONTROL TESTING WAS PERFORMED. LEVEL 1 CONTRL SOLUTION TESTED OUT OF RANGE (TOO HIGH) WHILE LEVEL 2 SOLUTION TREATED WITHIN THE ACCEPTABLE RANGE (VALUES NOT PROVIDED). A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT, AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention