BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1952477 · Received January 7, 2011

    Report

    Report Number
    1823260-2011-00102
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 4, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM BLOOD GLUCOSE RESULTS OF 450 MG/DL AND 152 MG/DL WITHIN 10 MINUTES. CUSTOMER STATES THAT CONTROLS WERE RUN WITHIN 24 HOURS OF RESULTS AND THEY PASSED. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE 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 551402

    Patients

    Seq Age Sex Outcome Treatment
    1