BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060084 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04697
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED A "HI" (GREATER THAN 600MG/DL) AND 236MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE REPORTER STATES THE CUSTOMER OBTAINED AN ADD'L COMPARISON WITH BLOOD GLUCOSE RESULTS 236MG/DL ON 503MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM WENT TO CUSTOMER AND RETURN REQUESTED.

    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 550091

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR FLEXERIL 20MG/DAY - 10YRS| PEPCID 40MG/DAY - 10YRS| LANOXIN 0.125MG/DAY - 2 MONTHS| ZESTRIL 10MG/DAY - 10YRS| SYNTHROID 0.112MG/DAY - 6X/WEEK-10YRS| PLAVIX 75MG/DAY - 10YRS| TENORMIN 75MG/DAY - 10YEARS| NOVOLOG SLIDING SCALE - UP TO 3X/DAY - 3YRS| LANTUS 18 UNITS/DAY - 3 YEARS