BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760938 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06196
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON HER ADVANTAGE SYSTEM AND A LAB INSTRUMENT WITH RESULTS OF 71 MG/DL ON HER METER AND 198 MG/DL AT THE LAB. NO QUALITY CONTROLS WERE RUN ON THE ADVANTAGE SYSTEM. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS 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 LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HUMALOG INSULIN SLIDING - 17U - 3-4 YRS| LANTUS 42 UNITS IN PM - 1.5 YRS