BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772056 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09520
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 1, 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

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE OF 71 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 20 MG/DL ON THE PARAMEDIC'S METER WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER STATED THAT THE PARAMEDICS WERE CALLED WHEN HE PASSED OUT TWO HOURS AFTER TAKING HIS NORMAL INSULIN AT DINNER TIME. HE REPORTED THAT THE PARAMEDICS TREATED HIM WITH OXYGEN, AN EKG, AND A GLUCOSE SHOT. NO OTHER ACTION OR TREATMENTS WERE 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 549847

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR COLESTID - 1 YEAR - 1 CUP ONCE DAILY| METOPROLOL - 1 YEAR - 0.25 MG ONCE DAILY| LISINOPRIL - 1 YEAR - 0.25 MG ONCE DAILY| LESCOL - 6 MONTHS - 0.25 MG ONCE DAILY| HUMALOG 75/25 - 3.5 YEARS - 30 UNITS DAILY