MAUDE Adverse Event Report: ABBOTT SRL ALINIQ AMS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number	03R89-21
Medical Device Problem Code	Application Security Problem (2882)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this issue found that this vulnerability impacts all marketed versions of aliniq ams and abbottlink.The investigation also identified that the vulnerability can only be exploited on ams-abbottlink systems within customer networks with poor network security (labs with no firewall, or an poorly configured firewall).A product correction letter has been issued to all customers where both abbottlink and aliniq ams are installed.The product correction letter notifies customers of the issue and provides the necessary actions to be taken to reduce the risk of exploitation of this vulnerability until they are contacted by their abbott representative to schedule the mandatory installation of the new version of abbottlink once it is available.
Event or Problem Description
The customer reported they were alerted with an error of account blocked in the database.After analysis, it was found that there were 10 attempts to log into the aliniq ams database.The next day there was another block on the oracle user again; an unblock was performed, dain was manually executed and the database was backed up.The running of axeda (abbottlink) on the server was identified, even though it was not connected due to a lack of a valid certificate.Abbottlink was disabled.There was no reported impact to patient management.

• Brand Name: ALINIQ AMS
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer (Section G): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14219323
• Report Number: 3004032053-2022-00004
• Device Sequence Number: 17513009
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: 03R89-21
• Device Catalogue Number: 03R89-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTTLINK 5.10, LIST N/A, SERIAL NUMBER, N/A
• Patient Sex: Unknown