BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1971758 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00468
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE BLOOD GLUCOSE RESULTS OF 209 MG/DL, 469 MG/DL, AND 344 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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 NA 551159

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR METFORMIN| LANTUS| ACTOS| HEARING AID| ANAPRIL| LOVASTATIN| "GLOUCOPROSOL"| "HYEROCHLOROTHIATIDE"