FDA Adverse Event Malfunction Summary report: N

AMBRA

MDR report key: 21034644 · Received December 30, 2024

Report

Report Number
21034644
Event Type
Malfunction
Date Received
December 30, 2024
Date of Event
August 6, 2024
Report Date
October 3, 2024
Manufacturer
DICOM GRID DBA AMBRA HEALTH DBA INTELERAD HOLDING
Product Code
LLZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

AMBRA (INTELESHARE) IS A CLOUD SHARING PLATFORM WHERE OUTSIDE INSTITUTIONS CAN SEND IMAGES TAKEN AT THEIR FACILITY TO OUR FACILITY TO BE UPLOADED INTO THAT PATIENTS CHART. AMBRA HAS A SYSTEM WHERE THEY TAKE THE DEMOGRAPHICS OF THE INCOMING IMAGES AND FIND A MATCH TO THE EPIC CHART AT THE FACILITY. IT WAS DISCOVERED THAT AMBRA WAS AUTOMATICALLY UPDATING PATIENT DEMOGRAPHICS (ON THEIR PLATFORM) WITH NONSPECIFIC CRITERIA CAUSING COMPLETE PATIENT CHANGES (EX: JOHN SMITH CHANGING TO JANE DOE). SOMETIMES THE PATIENT HAD SOME SIMILARITY EITHER IN DOB, A FEW LETTERS IN THE NAME, ETC. THIS WOULD HAPPEN BEFORE THE IMAGES EVEN HIT THE FILE ROOM STAFF AMBRA WORKQUE SO THAT WHEN OUR STAFF DID THE PHIR LOOKUP, IT LOOKED AS IF IT MATCHED BECAUSE IT DID (THIS IS BECAUSE THE INFORMATION WAS CHANGED IN AMBRA'S SYSTEM WITHOUT INTERVENTION FROM OUR FACILITY'S STAFF, SO WHEN OUR STAFF COMPARED OUR PATIENT INFORMATION IN EPIC, IT MATCHED WHAT AMBRA SAID, BUT THE IMAGE IN QUESTION WAS FOR A COMPLETELY DIFFERENT PATIENT). AMBRA ALSO AUTOMATICALLY CHANGED THE PATIENT DEMOGRAPHICS TO THE INCORRECT DEMOGRAPHICS SO THAT IF YOU WERE TO LOOK AT THE IMAGES IN PACS OR EPIC, IT WOULD LOOK LIKE YOU ARE VIEWING THAT PATIENTS IMAGES WHEN IN REALITY THOSE IMAGES ARE ANOTHER PATIENT'S. WHEN BROUGHT TO THE ATTENTION OF AMBRA VIA A TICKET BEING PLACED, AMBRA RESPONDED THAT THIS WAS NOT THE FAULT OF THEIR PRODUCT AND THEREFORE DEEMED NOT A REPORTABLE INCIDENT. ANOTHER INCIDENT WAS FOUND BY FACILITY STAFF ON A LATER DATE. AT THIS TIME AMBRA AGAIN TRIED TO CLOSE THIS TICKET REFERENCING THE ABOVE RESPONSE, HOWEVER OUR STAFF PUSHED FOR FURTHER INVESTIGATION. WE RECEIVE A LARGE NUMBER OF IMAGES FROM A SINGLE OUTSIDE INSTITUTION, THEREFORE OUR STAFF REACHED OUT TO THIS INSTITUTION TO SEE IF INSTITUTION TO INSTITUTION COULD BE ACHIEVED. IT WAS UNABLE TO BE REMEDIED WITHOUT AMBRA'S HELP, BUT LOGS WERE PROVIDED TO AMBRA AT THIS TIME. OUR ORGANIZATION REACHED OUT TO EPIC FOR ASSISTANCE WITH A RESOLUTION DUE TO THE AMBRA PLATFORM BEING INTEGRATED WITH EPIC. IN A MEETING WITH EPIC AND AMBRA, IT WAS CONFIRMED THIS ISSUE WAS DUE TO AN ISSUE ON AMBRA'S PLATFORM CREATING AN AUTO-MATCH WHICH AUTOMATICALLY UPDATES THE PHI. AMBRA PUSHED OUT AN UPDATE TO 'TURN OFF' THEIR SWITCH WHICH CREATES THIS AUTO-UPDATE. THERE WAS AN ISSUE WITH THE UPDATE WHICH ALLOWED THE AUTO-MATCH FUNCTION TO RETURN, BUT AMBRA WAS ABLE TO CLEAN UP THE AFFECTED RECORDS AND HAS CONFIRMED THE AUTO-UPDATE FUNCTION REMAINS OFF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2429598 AMBRA SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ DICOM GRID DBA AMBRA HEALTH DBA INTELERAD HOLDING

Patients

Seq Age Sex Outcome Treatment
1 NA Prefer Not To Disclose