MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number	8.17.32.03
Medical Device Problem Code	Unauthorized Access to Computer System (3025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A collaborative investigation was completed by data innovations (manufacturer), roche diagnostics (distributor), and mayo clinic rochester (user facility) for a report that after an instrument manager (im) upgrade process, users were able to login to im using an incorrect and/or no password.Investigation determined that while the upgrade process was in progress, a user shut down the cache database which prevented the updated dlls (dynamic link library) containing the updated ldap (lightweight directory access protocol) logic from loading.When the process was interrupted by the user, the updated code for ldap user authentication and verification method was not properly installed and therefore impacted the ability for previously configured usernames and passwords to be verified.The upgrade instructions inform users to "wait while the setup copies files, and iis and cache are upgraded.If prompted to restart your system, select no.Select finish on install shield wizard complete window." the user facility is not aware of any unauthorized access and is not aware of any impact to patients at this time.
Event or Problem Description
A representative from the distributor reported on (b)(6) 2023, that after a user facility completed an upgrade of instrument manager software, the ldap authentication method allowed configured users to log in with incorrect or missing passwords.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 17981328
• Report Number: 1225673-2023-00007
• Device Sequence Number: 19459193
• Product Code: JQP
• UDI-Device Identifier: B180IMB028170
• UDI-Public: +B180IMB028170/$$78173203/16D202302228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8.17.32.03
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/20/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown