BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2083409 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02493
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 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
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR ADVANTAGE SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF "OVER 300" MG/DL ON ADVANTAGE SYSTEM 1, "IN THE 100'S" MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. NO LOT NUMBER OR EXPIRATION DATE PROVIDED FOR ADVANTAGE SYSTEM 2 . REPORTED NO ADVERSE EVENT. 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 551218

    Patients

    Seq Age Sex Outcome Treatment
    1 METFORMIN