BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1053178 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04321
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 27, 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 DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 540 MG/DL, 371 MG/DL, 229 MG/DL, 406 MG/DL, 317 MG/DL, 228 MG/DL AND 209 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTEDLY 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 550032

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HUMALOG SLIDING SCALE| LANTUS 60-70 UNITS ONCE DAILY