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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported the aliniq ams auto-validated a discrepant alinity i afp (alpha1 fetoprotein) result for one patient sample.Multiple samples were being run for the alinity i afp (alpha1 fetoprotein) and the analyzer generated error code 1094 - unable to process test, no reagent cartridge available.All samples were repeated with a dilution factor updated by the user, and generated results of <16.6.Four out of five of the samples were held in ams and manually validated by the customer, and one sample auto-validated.The following information was provided: sid (b)(6) - result validated by user = <16.6, correct result = 4.7.Sid (b)(6) - validated by user = <16.6, correct result = <1.7.Sid (b)(6) - validated by user = <16.6, correct result = 9.5.Sid (b)(6) - auto-validated result = <16.6, correct result = 4.8.Sid (b)(6) - validated by user = <16.6, correct result = 5.7.There was no impact to patient management reported.
Event or Problem Description
The customer reported the aliniq ams auto-validated a discrepant alinity i afp (alpha1 fetoprotein) result for one patient sample.Multiple samples were being run for the alinity i afp (alpha1 fetoprotein) and the analyzer generated error code 1094 - unable to process test, no reagent cartridge available.All samples were repeated with a dilution factor updated by the user, and generated results of <16.6.Four out of five of the samples were held in ams and manually validated by the customer, and one sample auto-validated.The following information was provided: sid (b)(6) - result validated by user = <16.6, correct result = 4.7, sid (b)(6) - validated by user = <16.6, correct result = <1.7, sid (b)(6) - validated by user = <16.6, correct result = 9.5, sid (b)(6) - auto-validated result = <16.6, correct result = 4.8, sid (b)(6) - validated by user = <16.6, correct result = 5.7.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation on the aliniq ams software included a review of data and information provided by the customer, ticket trending review, and labeling review.Per the investigation, error flag 1094 occurred on the alinity i at another laboratory site where the sample originated because no reagent was onboard.Laboratory staff manually updated the dilution factor to 1:10, causing results to appear as <16.6 in ams.Five samples were run and gave <16.6 results.One out of the five samples were auto validated in ams.Log analysis shows this sample was manually set to rerun by laboratory personnel prior to result transmission which was the only difference from the four samples held in ams.Review of the ams rules and results following the incident showed no additional <16.6 results were generated.A review of tracking and trending for the aliniq ams software did not identify an increase in complaint activity related to the complaint issue.The device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue described in the current complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency was identified with the aliniq ams software, version 3.03.

• 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: 23973549
• Report Number: 3004032053-2026-00001
• Device Sequence Number: 9152323
• Product Code: JQP
• UDI-Device Identifier: 00380740212575
• UDI-Public: (01)00380740212575(10)3.03
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/05/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/05/2026
• 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