BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1930549 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07510
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE BLOOD GLUCOSE RESULTS OF 54 MG/DL, 101 MG/DL, AND 116 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 551244

    Patients

    Seq Age Sex Outcome Treatment
    1 089 YR GLIPIZIDE| COUMADIN| JANUVIA| DEFIBRILLATOR| PACEMAKER