BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1791985 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04720
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED: THE LONGER THAN USUAL TIP WAS NOTICED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 468 MG/DL AND 444 MG/DL MG/DL ON ADVANTAGE SYSTEM 1, 138 MG/DL AND 149 ON ADVANTAGE SYSTEM 2 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 551248

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR LONG ACTING INSULIN| BLOOD PRESSURE MONITOR| SHORT ACTING INSULIN