BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1823783 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05216
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 30, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED ERROR CODE MESSAGES. NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 430 MG/DL, 417 MG/DL AND 200 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 551195

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR VITAMIN D CALCIUM| TOPROL METOPROLOL| GLIMEPIRIDE| ANASTROZOLE| LEVOTHYROXINE| DIOVAN