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

Catalog Number	03R89-65
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported the aliniq ams will cancel the hil index (hemolysis, icteric, lipemia) order on samples that had a corresponding assay that was canceled.This was identified when the customer found multiple samples that had no hil measurements completed on them.After further review, an aliniq ams rule was configured incorrectly.This rule is responsible for adding hil orders to certain defined tests that the lis sends to the ams.No impact to patient management was reported.
Event or Problem Description
The customer reported the aliniq ams will cancel the hil index (hemolysis, icteric, lipemia) order on samples that had a corresponding assay that was canceled.This was identified when the customer found multiple samples that had no hil measurements completed on them.After further review, an aliniq ams rule was configured incorrectly.This rule is responsible for adding hil orders to certain defined tests that the lis sends to the ams.No impact to patient management was reported.
Additional Manufacturer Narrative
The investigation confirmed a misconfiguration rule responsible for managing hil tests in lab orders transferred from the laboratory information system (lis) to the ams.The cancellation parameter of the rule was inadvertently enabled.The laboratory used two analyzers (vista and alinity ci) connected to different middleware but interfacing with the same lis.When samples with tests initially completed on the vista analyzer were moved to the alinity, the lis sent cancellation messages for the tests already completed.These cancellations triggered the removal of hil tests from the orders as a result of the misconfiguration.The issue was resolved through a configuration rule and verified correct operation at the customer site.A review of tracking and trending did not identify an increase in complaint activity related to the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation no systemic issue or deficiency with the aliniq ams was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21751073
• Report Number: 3004032053-2025-00008
• Device Sequence Number: 8220644
• Product Code: JQP
• UDI-Device Identifier: 00380740212575
• UDI-Public: (01)00380740212575(10)3.03
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Catalogue Number: 03R89-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown