BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISCOVERY ST

    MDR report key: 2089542 · Received March 31, 2011

    Report

    Report Number
    2126677-2011-00025
    Event Type
    Other
    Date Received
    March 31, 2011
    Date of Event
    November 15, 2010
    Report Date
    March 31, 2011
    Manufacturer
    GE MEDICAL SYSTEMS LLC
    Product Code
    KPS
    PMA / PMN Number
    K041543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL TEST WAS PERFORMED (B)(6) 2010, HOWEVER, THE ERROR WAS NOT DISCOVERED UNTIL THE LAST WEEK OF (B)(6) 2011. A GE HEALTHCARE SERVICE TEAM VISITED THE SITE TO TEST THE SYSTEM AND THE SITE'S REPORTED WORKFLOW. THE ERROR COULD NOT BE REPRODUCED. THE SYSTEM LOGS WERE EXAMINED AND THERE WERE NO ERRORS RELATED TO THE EVENT. THERE WAS NO EQUIPMENT MALFUNCTION. THERE WERE MULTIPLE OPPORTUNITIES TO RECOGNIZE THAT INCORRECT PT INFO WAS BEING USED DURING THE EXAM AS THE PT INFO IS AVAILABLE THROUGHOUT - FROM SET-UP THROUGH THE EXAM COMPLETION. THE TECHNOLOGIST DID NOT CONFIRM THAT PT INFO ENTERED ON THE SCANNER CONSOLE WAS CONSISTENT WITH THE PT BEING SCANNED. THE TECHNOLOGIST RECOGNIZED THE ERROR AFTER THE IMAGES HAD BEEN SENT, BUT THE EXAM WAS NOT CORRECTED PRIOR TO READING. SINCE THE INDICATIONS BETWEEN THE PTS WERE CLOSED, THE RADIOLOGIST IN THE READING ROOM DID NOT FLAG A POSSIBLE INCORRECT PT ISSUE. THIS EVENT IS ATTRIBUTED TO USER ERROR. THE SITE INFORMED GE HEALTHCARE THAT THEY HAVE HELD EDUCATIONAL MEETINGS WITH THE TECHNICAL STAFF INCLUDING A NEW QUALITY CONTROL PROCESS TO AVOID THIS TYPE OF ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED UNNECESSARY TREATMENT FOLLOWING A POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET/CT) EXAM DUE TO A PT DATA MISMATCH ERROR. THE SITE HAD ACQUIRED AN EXAM AFTER MANUALLY INPUTTING THE INCORRECT PT'S NAME INTO THE FIRST EXAM RECORD. THE ISSUE WAS DETECTED AFTER THE FIRST PET/CT EXAM WAS COMPLETED WHEN THE SECOND PT ARRIVED FOR THEIR EXAM. THE IMAGES WERE CORRECTED, HOWEVER, THE SITE HAD ALREADY SENT A COMPACT DISK WITH THE INCORRECT EXAM INFO TO THE READING PHYSICIAN. THE TWO PTS THAT WERE INADVERTENTLY CONFUSED WITH EACH OTHER HAD THE SAME INDICATIONS FOR WHY THE SCAN WAS PERFORMED. THE PHYSICIAN AT THE SITE DESCRIBED THE TREATMENT AS UNNECESSARY BUT NOT CRITICAL. THE SPECIFIC TREATMENT OR PT OUTCOME HAVE NOT BEEN SHARED WITH GE HEALTHCARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY ST EMISSION COMPUTED TOMOGRAPHY SYSTEM KPS GE MEDICAL SYSTEMS LLC 5105797

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other