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

Catalog Number	03R89-21
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a configuration error after adding a new analyzer on the aliniq ams.The customer reported that there was a configuration error when the cs coagulation analyzer was added to the ams to replace the acl top coagulation analyzer.The results from the cs analyzer were sent to the lis indicating they were generated on the acl top and, therefore, a mismatch in the reference ranges occurred due to the difference in platforms.There were numerous samples affected by this since (b)(6) 2025.The customer indicated there was no delayed or missed treatment and no physicians contacted the laboratory with concerns about the results reported out.The customer noticed the issue in the lis, corrected it manually in the lis, and notified physicians of the issue.There was no reported impact to patient management due to the issue.
Additional Manufacturer Narrative
The complaint investigation for mismatch in reference ranges due to a configuration error when the cs coagulation analyzer was added to the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.The investigation revealed that on labonlinelink, the qpl rule for sending results to the lis was incorrectly configured on the acl analyzer, resulting in the wrong mapping of the analyzer id.This led to a mismatch in the reference range.Review of the qpl history indicated that these changes were likely made on march 21st, when new instruments were configured to replace the old ones by an abbott service representative.The incorrect configuration with the old instruments was removed from the middleware, which resolved the issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams software, version 2.08, was identified.
Event or Problem Description
The customer observed a configuration error after adding a new analyzer on the aliniq ams.The customer reported that there was a configuration error when the cs coagulation analyzer was added to the ams to replace the acl top coagulation analyzer.The results from the cs analyzer were sent to the lis indicating they were generated on the acl top and, therefore, a mismatch in the reference ranges occurred due to the difference in platforms.There were numerous samples affected by this since (b)(6) 2025.The customer indicated there was no delayed or missed treatment and no physicians contacted the laboratory with concerns about the results reported out.The customer noticed the issue in the lis, corrected it manually in the lis, and notified physicians of the issue.There was no reported impact to patient management due to the issue.

• 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: 21844378
• Report Number: 3004032053-2025-00012
• Device Sequence Number: 15416760
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: (01)00380740158255(10)2.08
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/07/2025

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: 03R89-21
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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