BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1003449 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01738
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 175 MG/DL BACK TO BACK WITH A RESULT OF 96 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER STATED THAT FIVE MINUTES BEFORE THE BACK TO BACK COMPARISONS, HE HAD TAKEN HIS NORMAL 500 MG OF METFORMIN AND 32 UNITS OF NOVOLIN N INSULIN. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT HE SELF-TREATED BY EATING BREAKFAST. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUESTED WAS MADE FOR THE RETURN OF SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 549633

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NOVOLIN N - 2 YEARS - 32 UNITS DAILY| NOVOLIN N - 2 YEARS - 30 UNITS NIGHTLY| METFORMIN - 6 YEARS - 500MG TAB 3 TIMES DAILY