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

Model Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported incorrect interpretation of results when using the aliniq ams base software.The customer stated that on (b)(6) 2023 a sample id (b)(6) was tested and generated a numeric result of 1.30 s/co but with no interpretation populating from the aliniq ams base software.However, a negative interpretation was sent from the ams to the customer¿s lis when the interpretation should have been positive.The previous hiv results for this sample have been correctly transmitted.One sample ran on (b)(6) 2023 with a result of 0.98 s/co and sent a negative interpretation.The other sample ran on (b)(6) 2023 with a result of 1.28 s/co and sent a positive interpretation.There was no impact to patient management reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Technical investigations were conducted by the local abbott informatic specialist involving the product sme and r&d engineers found that, when the quantitative/numeric result came from the instrument (alinity i), aliniq ams was unable to add the interpretation/qualitative result to this specific request.Although aliniq ams failed to add the interpretation result, a wrong interpretation (negative) comment was auto validated by aliniq ams and sent to lis.The incorrect interpretation result released by aliniq ams was due to a human error during the configuration the aliniq ams system which led to the issue described in the complaint.The abbott informatic technical specialist did not consider the interactions between the behavior of the aliniq ams worklists adding tests that already exist on another active worklist, as well as the rule requirements of adding tests that consequently add comments to an existing test.To address this scenario a configuration change was performed by the abbott engineer: two aliniq ams rules were configured to include qualitative / interpretation tests (e.G., hivagabi) whenever the lis sends request only for quantitative/numeric tests.Data and information provided were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did not identify any complaints similar to the issue under review.A device history record was reviewed and did not identify any non-conformances, deviations, or potential non-conformances related to the issue under review.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the aliniiq ams base software version 3.01, list 03r89-62.
Event or Problem Description
The customer reported incorrect interpretation of results when using the aliniq ams base software.The customer stated that on (b)(6) 2023 a sample id (b)(6) was tested and generated a numeric result of 1.30 s/co but with no interpretation populating from the aliniq ams base software.However, a negative interpretation was sent from the ams to the customer¿s lis when the interpretation should have been positive.The previous hiv results for this sample have been correctly transmitted.One sample ran on (b)(6) 2023 with a result of 0.98 s/co and sent a negative interpretation.The other sample ran on (b)(6) 2023 with a result of 1.28 s/co and sent a positive interpretation.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17084319
• Report Number: 3004032053-2023-00017
• Device Sequence Number: 5907224
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 07/21/2023

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 Model Number: 03R89-62
• Device Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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: ALINIQ AMS BASE SOFTWAR, 03R89-22, OCE00919_002.; ALINIQ AMS BASE SOFTWAR, 03R89-22, OCE00919_002.
• Patient Sex: Unknown