BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1140598 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06490
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 550078, EXPIRATION DATE 04/30/2009). REFERENCE MEDWATCH REPORT FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 162 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 71 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATES HE SELF-TREATED WITH ORANGE JUICE AND A SANDWICH. NO THER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 550078

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR METFORMIN - 2.5 MG TWICE DAILY