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

Model Number 03R89-21

Device Problem Application Security Problem (2882)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 299276169
• Report Number: 3004032053-2022-00004
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ABBOTTLINK 5.10, LIST N/A, SERIAL NUMBER, N/A