BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770878 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09815
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 279MG/DL BACK TO BACK WITH A RESULT OF 110MG/DL WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART ON THE ADVANTAGE SYSTEM. NO HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS WERE REPORTEDLY EXPERIENCED BY THE REPORTER. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INSULIN TYPE UNK - DOSAGE UNK