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

Catalog Number 03R89-20

Device Problem Computer System Security Problem (2899)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Catalog no; unique identifier (udi #): ams 2.06; catalog no 03r89-01; udi- n/a.Ams 2.07 (including patches)/alinity iq ams 2.07.2; catalog no 03r89-20; udi- n/a.Aliniq ams 2.08 (including patches); catalog no 03r89-21; udi- (b)(4).Aliniq ams 2.09; catalog no 03r89-23; udi- (b)(4).Aliniq ams 2.10; catalog no 03r89-24; udi- (b)(4).Aliniq ams 2.11; catalog no 03r89-47; udi- (b)(4).Aliniq ams 2.12; catalog no 03r89-48; udi- (b)(4).Abbottlink has no ln or sn.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

Abbott received a security vulnerability notification from ptc, the supplier who provides the software used in abbottlink, which resides on a customer-owned server.Within the overall software, the axeda desktop server is used to enable remote screen sharing through an abbottlink connection.The identified vulnerability could allow control of the operating system of the server where the software is installed.This vulnerability only impacts customer sites where both aliniq ams and the abbottlink axeda desktop server are installed when: the attacker has credentialled access to the customer network.The attacker knows the abbott-controlled axeda desktop server password; the attacker can connect to a specific port on the axeda desktop server.If the axeda vulnerability is exploited, the attacker could gain access through the axeda desktop server to aliniq ams services which has the potential for a delay in patient results, incorrect results, and/or data privacy issues.There have been no known exploits of this vulnerability on the aliniq ams.

Manufacturer Narrative

This emdr is being submitted as the attachment a (indicated in section d4- serial no) was inadvertently not attached to the initial emdr submission.Attachment a has now been attached to this submission.

• 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: 13981119
• MDR Text Key: 298234785
• Report Number: 3004032053-2022-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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 Catalogue Number: 03R89-20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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; ABBOTTLINK 5.10