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	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed the aliniq ams reported the hpvother, which is a combined placeholder for the hpv other a and hpv other b, as negative result even though the hpv result was other hr hpv a, should have resulted as positive.Hpv ¿other¿ results are consolidated into a single output test (hpvother), which conflicted with the existing validation rule by evaluating multiple outcomes (other a and other b) against one combined result.All patient results were blocked and held in the lis and no results were released out of the laboratory.A qpl adjustment was implemented to ensure the rule correctly interprets the combined hpv other results and produces a consistent outcome.No impact to patient management was reported.
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.
Additional Manufacturer Narrative
The investigation identified the issue stems from how the validation rule was originally configured.The customer¿s existing hpv rule was configured to evaluate hpv ¿other a¿ and ¿other b¿ as separate results.However, in the aliniq ams, these results are consolidated into a single combined output.This mismatch conflicted with the rule logic, which attempted to evaluate multiple discrete outcomes against the merged result, causing the system to incorrectly interpret the outcome as negative.A qpl adjustment was implemented to align the rule logic with the combined hpv other output, ensuring correct interpretation and consistent result generation.A review of complaint and trending data for the aliniq ams did not identify any similar issues related to the current issue.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the investigation, the aliniq ams middleware is performing as intended, no systemic issue or deficiency of the aliniq ams middleware was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed the aliniq ams reported the hpvother, which is a combined placeholder for the hpv other a and hpv other b, as negative result even though the hpv result was other hr hpv a, should have resulted as positive.Hpv ¿other¿ results are consolidated into a single output test (hpvother), which conflicted with the existing validation rule by evaluating multiple outcomes (other a and other b) against one combined result.All patient results were blocked and held in the lis and no results were released out of the laboratory.A qpl adjustment was implemented to ensure the rule correctly interprets the combined hpv other results and produces a consistent outcome.No impact to patient management was reported.

• 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: 24544175
• Report Number: 3004032053-2026-00004
• Device Sequence Number: 18488290
• 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): 04/13/2026

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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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