BEUDAMED
    FDA Adverse Event Other Summary report: N

    AYCAN WORKSTATION OSIRIX PRO

    MDR report key: 1544220 · Received November 24, 2009

    Report

    Report Number
    3003895711-2009-00001
    Event Type
    Other
    Date Received
    November 24, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 13, 2009
    Manufacturer
    AYCAN DIGITALSYSTEME GMBH
    Product Code
    LLZ
    PMA / PMN Number
    K063470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE ABOVE DESCRIBED OCCURRENCE IS NOT CAUSED BY OUR SYSTEM, WE BELIEVE THIS MIGHT NOT BE AN OCCURRENCE ACCORDING 21 CFR 803. BUT BECAUSE THIS MALFUNCTION OF THIS THIRD PARTY SOLUTION IS CAUSING OUR SYSTEM TO DISPLAY INCORRECT INFO WE DECIDED TO REPORT THIS IN ORDER TO REDUCE THE RISK OF MISDIAGNOSIS. AS THIS ISSUE ONLY HAPPENS IN COMBINATION OF THE FOLLOWING SITUATIONS WE SEE THE RISK OF REOCCURRENCE TO BE MARGINAL. CONFIG MISTAKE OF THIRD PARTY COMPANY'S TECH. THIRD PARTY SOFTWARE DOESN'T DETECT CONFIGURATION ERRORS. MODALITY DOES NOT DETECT DOUBLE UIDS. WORKSTATION WHERE NEW DATA IS BEING DISPLAYED (WITH DOUBLE UIDS) HAS "OLD" DATA (WHERE UIDS WERE ALLOCATED THE FIRST TIME) STILL AVAILABLE. PLANNED CORRECTIVE ACTION: SECURITY ALERT NOTIFICATION AT ALL CUSTOMERS AND RESELLERS (COPY TO MEDWATCH). SECURITY ALERT NOTIFICATION TO LEADERSHIP TEAM OF THE FREE OPEN-SOURCE PROJECT (B)(4) (WHICH "AYCAN'S (B)(4) PRO" IS BUILT ON). SECURITY ALERT NOTIFICATION TO THE ENTIRE USER GROUP (MAILING LIST) OF THE OPEN SOURCE SOFTWARE. SOFTWARE UPDATE TO HELP FURTHER DISCOVER INCORRECTLY IDENTIFIED DATA SENT TO WORKSTATION (AS MUCH POSSIBLE WITH AVAILABLE DATA). INDICATION: AYCAN IS NOT THE MFR/ SUPPLIER OF THE FREE AVAILABLE OPEN-SOURCE SOFTWARE (B)(4).

    Description of Event or Problem · 1

    A THIRD PARTY (NON AYCAN) DICOM-MODALITY-WORKLIST-SERVER SOLUTION, DESIGNED TO GENERATE STUDY-INSTANCE-UID'S IN CONNECTION WITH PT DATA FOR VARIOUS MODALITIES WAS REINSTALLED BY A THIRD PARTY COMPANY AT ONE OF AYCAN'S CUSTOMER LOCATIONS. AFTER A SYSTEM MANIPULATION BY A TECHNICIAN OF THIS THIRD PARTY COMPANY, THE SYSTEM ABOVE STARTED TO ALLOCATE STUDY-INSTANCE-UID'S, WHICH HAVE ALREADY BEEN USED FOR PRIOR PT DATA INFO. THIS MALFUNCTION CAUSED THE SYSTEM TO GENERATE IMAGE DATA SETS WITH NOT UNIQUE STUDY INSTANCE UIDS. THESE INCORRECT DATA SETS WERE SENT, FOR DIAGNOSIS, TO AYCAN'S WORKSTATION OSIRIX PRO AND OTHER WORKSTATIONS. AS A RESULT OF THIS THIRD PARTY COMPANY'S SYSTEM MALFUNCTION INCORRECTLY IDENTIFIED IMAGE DATA WAS DISPLAYED WITH INCORRECT PT DATA. DUE TO THE FACT THAT THE CUSTOMER IMMEDIATELY NOTICED THE MALFUNCTION OF THE SYSTEM NO PT OR OTHERS WERE HARMED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AYCAN WORKSTATION OSIRIX PRO LLZ - PICTURE ARCHIVING AND COMMUNICATION LLZ AYCAN DIGITALSYSTEME GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1