BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052293 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04288
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 354 MG/DL BACK TO BACK WITH A RESULT OF 135 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 422 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 169 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTER ALLEGED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 278 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 135 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. REPORTER INDICATED HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT 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 549833

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR METFORMIN| LIPITOR - 1 YEAR| BENICAR HCT - 1 YEAR