BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 769076 · Received August 9, 2006

    Report

    Report Number
    1823260-2006-04048
    Event Type
    Malfunction
    Date Received
    August 9, 2006
    Date of Event
    July 15, 2006
    Report Date
    July 19, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE FOLLOWING BACK TO BACK READINGS ON THE SAME DEVICE OF 392 MG/DL AND 186 MG/DL. CONTROL VALUES IN RANGE 07/14/2006, BUT CONTROLS WERE NOT RUN PRIOR TO TESTING 07/15/2006. RETURN REQUESTED OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS * 549278

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR DURATION UNKNOWN| DOCUSATE: 4 YRS| ACCU-CHEK ADVANTAGE METER| COMBIVENT: 6 YRS| METFORMIN: 6 WEEKS| 2LV CONTROLS| ACCU-CHEK COMFORT CURVE| SIMVASTATIN: 2 YRS| INSULIN PUMP| NOVALOG INSULIN| LISINOPRIL: 8 MONTHS| ASPIRIN: 4 YRS