BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU- CHEK COMPACT

    MDR report key: 614181 · Received June 1, 2005

    Report

    Report Number
    1823260-2005-01410
    Event Type
    Malfunction
    Date Received
    June 1, 2005
    Date of Event
    February 15, 2005
    Report Date
    May 21, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THE DEVICE GAVE A RESULT BETWEEN 200 AND 240 MG/DL. THE CUSTOMERS' RECENT HBA 1C RESULT WAS 6.5. CUSTOMER FEELS THEY ARE TAKING TOO MUCH INSULIN BASED ON THE RESULTS. CONTROLS WERE IN USE, UNKNOWN IN IN RANGE. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE BUT CUSTOMER THREW AWAY GLUCOSE STRIPS AND CONTROLS AND DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other