BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE COMPANION 2 METER

    MDR report key: 118162 · Received September 3, 1997

    Report

    Report Number
    1220459-1997-00145
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 1, 1997
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION CONFIRMS AN INCORRECT CALIBRATION CODE BEING OBTAINED. THE INCORRECT CALIBRATION CODE, IF USED TO PERFORM AN ASSAY, COULD RESULT IN HIGHER THAN EXPECTED READINGS. THESE RESULTS UNDER CERTAIN CONDITIONS. COULD HAVE ADVERSE CLINICAL EFFECTS. NO INJURIES WERE REPORTED IN THE FIELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability