BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 872095 · Received March 21, 2007

    Report

    Report Number
    1823260-2007-02284
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Date of Event
    February 25, 2007
    Report Date
    March 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 150MG/DL, 86MG/DL, AND 134MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. CUSTOMER ALSO REPORTEDLY OBTAINED RESULTS OF 40MG/DL AND 90MG/DL WITHIN 3 MINUTES ON THE ADVANTAGE TEST SYSTEM. NO ACTION WAS REPORTEDLY TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. INFORMATION SUGGESTS COMPARISON PERFORMED IN THE HOME. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549202, EXPIRATION DATE 09/30/2007, CATALOG 2030365.

    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 CORP. * 549202

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR METOPROLOL - 25MG 1 1/2 PILLS 2X DAILY| LISINOPRIL .5MG/ 1 X DAY| CLOPIDOGREL - LONG TIME 1X DAY, 75MG| METFORMIN - 6YRS 2 DAYS, 1000MG| ATORVASTIN - 80MG/ 1X DAY| GLIPIZIDE - 10MG/ 1 PILL MORNING/ 2 PILLS EVENING