BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XELERIS WORKSTATION

    MDR report key: 8122337 · Received December 1, 2018

    Report

    Report Number
    9613299-2018-00002
    Event Type
    Injury
    Date Received
    December 1, 2018
    Date of Event
    June 14, 2018
    Report Date
    January 25, 2019
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K153355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT IN THEIR DEPARTMENT THEY USED THE WRONG VALUE FOR RENAL FUNCTION IN THEIR REPORT, WHICH CAN LEAD TO A MISDIAGNOSIS AND SPECIFICALLY IN THIS CASE AS REPORTED BY THE CUSTOMER, A DELAY IN THE TREATMENT TO PRESERVE RENAL FUNCTION. THE KIDNEY FUNCTION REPORT WAS MISTAKENLY DERIVED FROM THE RELATIVE PERFUSION VALUE RATHER THAN RELATIVE UPTAKE VALUE, CALCULATED AND DISPLAYED IN THE RENAL ANALYSIS APPLICATION. A TRAINED AND QUALIFIED NUC MED PHYSICIAN WOULD KNOW THE MEANING OF THE UPTAKE AND PERFUSION VALUES, AS IT IS A STANDARD PROCEDURE IN THE NUC MED GUIDELINE AND PUBLICATIONS AND WILL THEREFORE KNOW HOW TO INTERPRET AND USE THEM. THUS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE ISSUE IS A USE ERROR READING AND INTERPRETING THE RELATIVE VALUES CALCULATED AND CORRECTLY DISPLAYED TO THE USER. NO SYSTEM MALFUNCTION OCCURRED. THE INVESTIGATION CONCLUDED THAT THE SOLE ROOT CAUSE IS A USE ERROR AND NO PROCESS ROOT CAUSE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A POTENTIAL FALSE NEGATIVE ISSUE DUE TO AN INACCURATE INTERPRETATION OF THE KIDNEY FUNCTION NUMBER WITH DETERIORATION IN RENAL FUNCTION FOR A PATIENT WITH KNOWN KIDNEY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961418 XELERIS WORKSTATION SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NX4WFS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other