BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE 2 SENSOR

    MDR report key: 39558 · Received August 26, 1996

    Report

    Report Number
    1220459-1996-09001
    Event Type
    Malfunction
    Date Received
    August 26, 1996
    Date of Event
    July 29, 1996
    Report Date
    August 22, 1996
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION CONFIRMS A MALFUNCTION WHERE A DEVICE WAS FOUND TO CONTAIN AN INVALID CALIBRATION CODE. IT IS BELIEVED THAT THIS WAS NOT A DEVICE MALFUNCTION, BU RATHER WAS A USER ERROR IN THAT THE USER UNINTENTIONALLY RECALIBRATED THE DEVICE. AS SUCH, THE CO HAS MODIFIED ITS LABEL COPY TO HIGHLIGHT THE POSSIBLE ERROR. NO INJURIES WERE REPORTED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE 2 SENSOR BLOOD GLUCOSE SENSOR CFR MEDISENSE, INC. NA T181

    Patients

    Seq Age Sex Outcome Treatment
    1 *