BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE II CARD

    MDR report key: 40605 · Received September 11, 1996

    Report

    Report Number
    1220459-1996-00010
    Event Type
    Malfunction
    Date Received
    September 11, 1996
    Date of Event
    August 8, 1996
    Report Date
    August 8, 1996
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    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. IF USED TO PERFORM AN ASSAY WITH TEST STRIPS FROM ANY REPORTED LOT, COULD RESULT IN HIGHER THAN EXPECTED RESULTS. NO INJURIES REPORTED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE II CARD BLOOD GLUCOSE MONITORING SYSTEM CFR MEDISENSE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability