BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE

    MDR report key: 3902802 · Received February 14, 2014

    Report

    Report Number
    3002807968-2014-00006
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 13, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JQP
    PMA / PMN Number
    K050869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROBLEM WAS CAUSED BY A MISUNDERSTANDING BETWEEN RADIOMETER AND THE CUSTOMER REGARDING HOW THE VERIFICATION SHOULD BE PERFORMED. RADIOMETER (B)(6) HAS IMPLEMENTED A CHECKLIST TO ENSURE THAT THIS TYPE OF MISUNDERSTANDINGS ARE AVOIDED IN THE FUTURE.

    Description of Event or Problem · 1

    DUE TO PROBLEMS WITH THE RADIANCE DATABASE A NEW DATABASE WAS INSTALLED ON THE SERVER AND THE SYS WAS RECONFIGURED. THIS WAS DONE REMOTELY BY RADIOMETER (B)(6) (VIA VPN). IT WAS AGREED BY PHONE THAT THE USER SHOULD VERIFY THE INSTALLATION AND ENSURE THAT THE UNITS WERE FORWARDED CORRECTLY. THE UNIT FOR THB WAS HOWEVER, NOT CHANGED FROM DEFAULT (G/DL) TO MMOL/L WHICH IS THE UNIT USED I (B)(6) AT THE HOSP. (B)(6) DO NOT HAVE THE CAPABILITIES TO SEE WHICH UNIT IS FORWARDED FROM RADIANCE AND THEREFORE THE RESULTS MEASURED IN G/DL WOULD BE SHOWN AS MMOL/L. THE CENTRAL LAB WAS CONTACTED BY CLINICIANS WHO FOUND THE RESULTS SUSPICIOUS AND THE ERROR WAS CORRECTED. IT WAS REPORTED THAT 193 PT SAMPLES WERE FORWARDED WITH INCORRECT UNIT, BUT NO PTS WERE ADVERSELY AFFECTED BY THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98044 RADIANCE RADIANCE VERSION 3.52 JQP RADIOMETER MEDICAL APS V. 3.52

    Patients

    Seq Age Sex Outcome Treatment
    1