BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 843162 · Received February 26, 2007

    Report

    Report Number
    1823260-2007-01634
    Event Type
    Malfunction
    Date Received
    February 26, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE IS ACCU-CHEK COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 559 MG/DL, 288 MG/DL, AND 206 MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549510, EXP 02/29/2008, CAT/2030381.

    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 * 549510

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NOVOLOG 70/30 - 20U 3X A DAY BEFORE MEAL| IMDUR - 2 MONTHS 30 MG/ 1X DAILY| ALBUTEROL - 3 YEARS| NOVOLIN - 3 MONTHS 15 UNITS/ 3X DAILY| SINGULAIR - 10 MG/ 1X DAILY| LISINOPRIL - 2 MONTHS 20 MG/ 1X DAILY| LUNESTA - 2MG ONCE A DAY| ADVAIR - 1 YEAR 500-50 /2X DAILY| EFFEXOR XR - 2 WEEKS 75 MG/ 1 X DAILY| PROZAC - 1 YEAR 20 MG/1 X DAILY| PYRIDIUM - 3 DAYS 100 MG/ 3X DAILY (9 TABLE)| GLUCOPHAGE - 3 MONTHS 1000MG/ 2X DAILY| PLAVIX - 6 MONTHS 75 MG/ 1X DAILY| SPIRIVA INHALER - 1 YEAR INHALER| AMBIEN - 2 MONTH 10 MG/ 1X DAILY