BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770703 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09416
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTED ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE OF 169 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 96 MG/DL ON THEIR DOCTOR'S METER WHEN TESTING WAS PERFORMED DURING A ROUTINE APPOINTMENT, LESS THAN 10 MINUTES APART. REPORTER STATED THAT ANOTHER COMPARATIVE TEST OF 164 MG/DL ON THEIR SAME SYSTEM WAS COMPARED WITHIN 10 MINUTES BACK TO BACK WITH A RESULT OF 89 MG/DL ON THEIR DOCTOR'S OTHER METER. 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 549631

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR CENTRUM - 5 YEARS, 1 TAB ONCE DAILY| PLAVIX - 6 MONTHS, 75MG ONCE DAILY| LOTREL - 5 YEARS, 520MG ONCE DAILY| NITROQUICK - TIME UNK, 4MG AS NEEDED| JANUVIA - 6 MONTHS, 100MG ONCE DAILY| ASPIRIN - 5 YEARS, 325MG ONCE DAILY| HYDROCODONE - 4 YEARS, 750MG AS NEEDED| METOPROLOL - 3 MONTHS, 25MG ONCE DAILY| MICARDIS - 5 YEARS, 80MG ONCE DAILY| ACTOS - 4 MONTHS, 45MG ONCE DAILY| TRICOR - 5 YEARS, 145MG ONCE DAILY| GLIPIZIDE - 2 YEARS, 10MG ONCE DAILY