BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1970666 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00413
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 9, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 245 MG/DL, WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    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 551255

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR LISINOPRIL| HUMALOG| LANTUS