BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1770684 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09402
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT 6:00 PM AND WHEN PERFORMING A BLOOD GLUCOSE TEST OBTAINED A READING OF 28 MG/DL ON ADVANTAGE SYSTEM. REPORTER WHEN LOOKING AT THE METER DISPLAY AT 6:12 PM, THE RESULT WAS 82 MG/DL AND STATED SHE WAS NOT LOOKING AT THE METER UPSIDE DOWN AT THE TIME. REPORTER INDICATED SHE WAS ABLE TO SELF TREAT WITH ORANGE JUICE AND NO OTHER ACTIONS WERE TAKEN OR TREATMENT WAS REPORTEDLY RECEIVED. IT WAS STATED THE RESULT OF 28 MG/DL COULD NOT BE LOCATED IN THE SYSTEM MEMORY. 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 ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR LANTUS - 3WKS - 10UNITS ONCE IN THE PM| HYDRALAZINE - 6MOS - 25MG ONCE IN THE AM| ALLOPURINOL - 1 YR - 300MG ONCE IN THE AM| THRYOXINE - 10 YRS - 112MCG ONCE IN THE AM| GABAPENTINE - 6 YRS - 800MG 2 TABLETS ONCE AM&PM| NYSTATIN - 3 WEKS - 1000UNITS 1 TSPN 4 TIMES DAILY| SPIRIVA - 3WKS - 18MG ONE DAILY IN THE AM| PREDNISONE - 10 YRS - 10MG TWO ONCE IN THE MORNING| FUROSEMIDE - 8 YRS - 40MG ONCE IN THE AM| DETROL LA - 1 YR - 2MG ONCE IN THE AM| RANITIDINE - 1 YR - 150 MG ONCE IN THE AM & PM| GLIPIZIDE - 3WKS - 5MG TWICE DAILY, AM AND NOON| METFORMIN - 3WKS - 500MG TWICE DAILY, AM AND NOON| OMEPRAZOLE - 1 YEAR - 20MG ONCE IN THE AM| AMBIEN - 2 YRS - 10MG ONCE IN THE PM| LIPITOR - 1 YR - 20MG ONCE IN THE AM| ALBUTEROL - 3WKS - 90MG 3TIMES DAILY, AM, PM, NOON| LORTAB - 6 YRS - 10MG AS NEEDED