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

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed that the ams is sending neutrophil absolute counts as percentages.This occurred due to ¿send to lis after validation¿ button/box on the ams was checked.Once the ¿send to lis after validation¿ box was unmarked, the issue was resolved.No impact to patient management was reported.
Event or Problem Description
The customer observed that the ams is sending neutrophil absolute counts as percentages.This occurred due to ¿send to lis after validation¿ button/box on the ams was checked.Once the ¿send to lis after validation¿ box was unmarked, the issue was resolved.No impact to patient management was reported.
Additional Manufacturer Narrative
While troubleshooting a neutrophil (neut) result upload issue, the 'send to lis after validation' option was inadvertently enabled to match other test configurations.However, the lis had applied internal rules that unintentionally converted absolute values to percentages.As the checkbox was enabled, validated results were automatically sent to the winpath (lis), which was not the intended workflow.The issue was resolved by disabling the option, instructing the customer to delete the affected results, and resending correct data from the ams.No deficiency of the middleware was identified.Device history record review revealed that there were no nonconformances or potential nonconformances related to the issue described in the current complaint.A review of the labeling addresses the customer¿s issue.Trending review did not identify any trends.Based on the investigation, no systemic issue or product deficiency was identified for the aliniq ams software (version 3.02), list 03r89-63.

• 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: 22052940
• Report Number: 3004032053-2025-00014
• Device Sequence Number: 14791293
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736
• 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): 06/18/2025

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: 03R89-63
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMS SATELLITE SITE, 03R89-57, (B)(6)
• Patient Sex: Unknown