BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1053168 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04314
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED BLOOD GLUCOSE COMPARISONS WITH RESULTS 266MG/DL, 561MG/DL, 181MG/DL AND 179MG/DL. ON THE ACCU-CHEK ADVANTAGE SYSTEM. TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT 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 550072

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR GLUCOTROL XL 20MG/DAY| HYDRALAZINE 300MG/DAY| "TENOLOL" 50MG/DAY| LIPITOR 40MG/DAY| "MANEDA" 20MG/DAY| DEMADEX 60MG/DAY