BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 872134 · Received March 21, 2007

    Report

    Report Number
    1823260-2007-02280
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Date of Event
    February 23, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF HI ON THE ADVANTAGE TEST SYSTEM AND 132MG/DL ON THE DOCTOR'S DEVICE. NO ACTION WAS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. COMPARISON REPORTEDLY PERFORMED AT THE DOCTOR'S OFFICE. NO QUALITY CONTROLS WERE USED. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 548881, EXPIRATION DATE 02/28/2007, 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. * 548881

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GLUCOTROL - 2YRS 20 2 X DAY| KLORIPIN - 1 YR APPROX. 1.0 MG/ 1X| HUMULIN 70/30 - 1YR| PROZAC - 1.5YRS 20MG 1X| LIPITOR - 10MG 1 X DAY| ZESTRIL - 20 MG 2X| FIORCET - 5YRS 1 TABLET 3X DAILY| HCTZ - 4YRS 25 MG 1X DAILY| LOPRES - 25MG 2 DAY| CLONIZINE - 6 MONTH 0.1MG| NORVASC - 25 MG 1X DAY