BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL700SERIES AND ABL800SERIES

    MDR report key: 687353 · Received March 13, 2006

    Report

    Report Number
    3002807968-2006-00018
    Event Type
    Malfunction
    Date Received
    March 13, 2006
    Date of Event
    February 9, 2006
    Report Date
    March 6, 2006
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DESCRIPTION IS ACCORDING TO STANDARD FOR MEDICAL DEVICES- CODING STRUCTURE FOR ADVERSE EVENT TYPE AND CAUSE ISO/TS 19218. SEE AE CAUSE TERM 540 AND 950. 540 CALIBRATION ERROR. INACCURATE RESULTS WITH MEDICAL MEASUREMENT DEVICES (E.G. FOR TEMPERATURE, MASS, PH, IVD TEST RESULTS) DUE TO INCORRECT CALIBRATION. 950 USER ERROR. AN ACT OR OMISSION OF AN ACT THAT HAS A DIFFERENT RESULT THAN THAT INTENDED BY THE MANUFACTURER OR EXPECTED BY THE OPERATOR CAUSING A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL700SERIES AND ABL800SERIES BLOODGAS ANALYZER CCE RADIOMETER MEDICAL APS * 754R0052N004

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other