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	04/03/2025
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.A1 - patient identifier: (b)(6) (total of 6 complete samples ids for 6 different patients) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported discrepancies in hbsag results for two samples (sid (b)(6) and sid (b)(6) where the ams system reported a value of 54, which differs significantly from the original values (100.862 and 5821.777, respectively).The results were incorrect due to manually overwriting or inserted with the barcode scanner.Additionally, the barcode scanners at the ams workstations were disabled due to continuous scanning of random barcodes, which could inadvertently alter sample results.Manual edits were found in the event history for various specimens, all linked to the ams user account "a".The examples of this were provided: sample: (b)(6), specimen: anti-hcv result: 1537.00.Specimen: albbcg result: 15.00 request: (b)(6).Specimen: che result: 9.29 request: (b)(6).Specimen: alkp result: 78.00 request: (b)(6).Specimen: alt result: 78.00 request: (b)(6).Specimen: ast result: 78.00 request: (b)(6).The customer confirmed that the incorrect results were not released out of the lab.There was no impact to patient management reported.
Additional Manufacturer Narrative
The investigation revealed that if a barcode scanner is set up to automatically send an "enter" after scanning, scanning a barcode once or multiple times quickly can accidentally enter and save incorrect results without the user realizing it.The event log showed the results were edited, but it¿s unclear whether the edits were made by a user or by the barcode scanner.To prevent recurrence, the barcode scanners were disabled from the ams stations and disabled automatic validation for manually edited results.Event history review revealed the results were incorrect due to manual overwriting or barcode scanner input errors.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, aliniq ams software (version 3.03) is performing as intended, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported discrepancies in hbsag results for two samples (sid (b)(6) where the ams system reported a value of 54, which differs significantly from the original values (100.862 and 5821.777, respectively).The results were incorrect due to manually overwriting or inserted with the barcode scanner.Additionally, the barcode scanners at the ams workstations were disabled due to continuous scanning of random barcodes, which could inadvertently alter sample results.Manual edits were found in the event history for various specimens, all linked to the ams user account "a".The examples of this were provided: sample: (b)(6), specimen: anti-hcv, result: 1537.00.Specimen: albbcg, result: 15.00, request: 270325436.Specimen: che, result: 9.29, request: 030425113.Specimen: alkp, result: 78.00, request: 270325019.Specimen: alt, result: 78.00, request: 270325019.Specimen: ast, result: 78.00, request: 270325019.The customer confirmed that the incorrect results were not released out of the lab.There was no impact to patient management 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: 21844270
• Report Number: 3004032053-2025-00011
• Device Sequence Number: 18070305
• Product Code: JQP
• UDI-Device Identifier: 00380740212575
• UDI-Public: (01)00380740212575(10)3.03
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 05/23/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/23/2025
• 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