BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1070128 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05219
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF APPROX 200MG/DL AND 64MG/DL ON THE VOICEMATE/ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR IRON - 1YR 25MG/DAY| NORVASC - 1YR 20-40MG/DAY| LASIX - LIFE LONG 20MG/DAY| LISINOPRIL - 8YRS 40MG/DAY| CALCIUM - 1200MG/DAY| MULTIVITAMIN - 8YRS| HUMALOG PEN - 8YRS SLIDING SCALE| VITAMIN D - 1YR 500MG/DAY| ZOLOFT - 100MG/DAY| LIPITOR - 1YR| ASPIRIN - 81MG/DAY| CRANBERRY TABLET - 1 MONTH 500MG/DAY