BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE II SENSOR

    MDR report key: 47910 · Received September 20, 1996

    Report

    Report Number
    1220459-1996-00017
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 14, 1996
    Report Date
    August 23, 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 REVEALED INCORRECT CALIBRATION CODE BEING OBTAINED. COMPLAINT ANALYSIS SHOWS THAT THIS INCORRECT CALIBRATION CODE, IF USED TO PERFORM ASSAY WITH TEST STRIPS FORM ANY REPORTED LOT, COULD RESULT IN HIGHER THAN EXPECTED RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability