BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761295 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06382
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 3, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 52 MG/DL, 214 MG/DL AND 179 MG/DL WHEN TESTS WERE PERFORMED WITHIN 5 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS AND TOOK 17 UNITS HUMULIN BASED ON THE 179 MG/DL RESULT. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICES 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 549616

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR NEBULIZER - 20% 10ML 4 TIMES DAILY| COREG - 12.5MG TWICE DAILY| FLUOXETINE - 20MG DAILY| ASPIRIN - 81MG DAILY| FUROSEMIDE - 80MG THRICE DAILY| LISINOPRIL - 30MG DAILY| HUMULIN - 15 YEARS - 36 UNITS AM, 17 UNITS PM| ALBUTEROL - 3.0MG 4 TIMES DAILY| OXYGEN - 30 YEARS - 2UNITS| MUCAMIST - THRICE DAILY| MUCINEX - 600MG TWICE DAILY| PREDNISONE - 8MG THRICE DAILY| IRON PILL - 325MG TWICE DAILY| TEMAZEPAM - 30MG DAILY| LEVOXYL - 0.088MG DAILY| LOVASTATIN - 40MG DAILY| IPRATROPIUM BROMIDE - 0.5MG 4 TIMES DAILY