BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1172571 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07029
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 349 MG/DL BACK TO BACK WITH A RESULT OF 142 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER STATED THAT A DIFFERENT TIME A RESULT OF 256 MG/DL WAS OBTAINED WITHIN 10 MINS OF A RESULT OF 125 ON THE SAME SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER STATED THAT AT A DIFFERENT TIME A RESULT OF 380 MG/DL WAS OBTAINED WITHIN 10 MINS OF A RESULT OF 110 ON THE SAME SYSTEM. REPORTER STATED HE TOOK INSULIN WITH THE 380 MG/DL RESULT AND HE FELT DIZZY, AGITATED AND WEAK 30 MINUTES LATER, SO HE SELF-TREATED WITH A SNICKERS BAR AND SUGAR. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER STATED THAT AT A DIFFERENT TIME A RESULT OF 440 MG/DL WAS OBTAINED WITHIN 10 MINUTES OF A RESULT OF 160 ON THE SAME SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE TO RETURN 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 550086

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 70/30 NOVOLOG- 1 YR| BYETTA- 8 MONTHS| SIMVASTATIN- 6 MONTHS