BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040390 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03810
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 260 MG/DL BACK TO BACK WITH A RESULT OF 38 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED SHE SELF-TREATED WITH A PROTEIN BAR AND REST. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER COULD NOT RECALL IF THE STRIPS USED WERE EXPIRED BUT DID STATE THERE WAS A POSSIBILITY THAT THEY WERE.

    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 47 YR METFORMIN - 14 YEARS - 500MG TWICE DAILY