BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780615 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08450
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 67 MG/DL AND 117 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. THE CUSTOMER REPORTED HAVING NO SYMPTOMS. THE CUSTOMER TOOK HIS NORMAL DOSE OF 10 MG GLYBURIDE AND ATE DINNER. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549521

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR ATORVASTATIN CALCIUM - 10 YEARS - 40 MG - DAILY| FINASTERIDE - 10 YEARS - 5MG - DAILY| PLAVIX - 5 YEARS - 75MG - DAILY| GLYBURIDE - 10 YEARS - 10MG - TWICE DAILY| BUFFERIN - 325MG - DAILY| DOXAZOSIN MESYLATE - 10 YEARS - 4MG - DAILY| OMEPRAZOLE - 8-10 YEARS - 20MG - DAILY| ATENOLOL - 8-10 YEARS - 25MG - DAILY| SULFASALAZINE - 8-10 YEARS - 500MG - 4 TIMES DAILY| EZETIMIBE - 3 YEARS - 10MG - DAILY| HCTZ - 10 YERAS - 25MG/37.5MG - ONCE DAILY| SULINDAC - 5-6 YEARS - 200MG - AS NEEDED| FOSINOPRIL - 10 YEARS - 40MG - TWICE DAILY| FOLIC ACID - 8-10 YEARS - 1MG - DAILY| "EQUATE" - DOSAGE UNK - 4 TIMES DAILY