BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2213146 · Received August 16, 2011

    Report

    Report Number
    1823260-2011-04372
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 600 MG/DL, 139 MG/DL AND 137 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551465

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR COLCHICINE (DAILY)| GLUCOSAMINE WITH CHONDROITIN (DAILY)| METFORMIN (TWICE DAILY)| PROBENECID (TWICE DAILY)| LISINOPRIL (DAILY)| GLIPIZIDE (TWICE DAILY)| ETHANOL (DAILY)| BLOOD PRESSURE CUFF| ACETAMINOPHEN (DAILY)