BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 692972 · Received March 27, 2006

    Report

    Report Number
    1823260-2006-01371
    Event Type
    Injury
    Date Received
    March 27, 2006
    Date of Event
    March 1, 2004
    Report Date
    March 13, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE DEVICE RESULTS WERE ERRATIC IN THE 300'S, HI, 463, 66, 62, 120 AND 229 MG/DL. THE RESULTS ARE FROM DIFFERENT TIMES AND DAYS. THE USER PASSED OUT AND WAS TREATED FOR HYPOGLYCEMIA BY THE EMTS. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE CFR ROCHE DIAGNOSTICS NA 549055

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization