BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760922 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06207
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HIS ADVANTAGE SYSTEM HAD BEEN READING IN THE 400S MG/DL AND WENT TO THE DOCTOR AND PHARMACY TO TEST GLUCOSE. REPORTER STATED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 415 MG/DL ON HIS ADVANTAGE SYSTEM COMPARED TO THE DOCTOR RESULT OF 79 MG/DL WHEN TESTING WAS PERFORMED 3-4 MINUTES APART. REPORTER ALSO STATED HIS SYSTEM READ 477 MG/DL COMPARED TO THE PHARMACY MEASUREMENT OF 116 MG/DL WHEN TESTING WAS PERFORMED 3-5 MINUTES APART. REPORTER INDICATED HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC OR HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO ACTIONS TAKEN AND NO TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE 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 549725

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR ACTOS 1.25 MOS - 15MG ONCE DAILY