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

Model Number	03R89-48
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during aliniq ams configuration by abbott, 379 iron and hdl results were released incorrectly before verification and lims build was completed.All the assays were disabled in the ams automation as required to prevent results from being generated in a live state.However, an ams specialist enabled the assays on (b)(6) 2023, and the customer found the results were then being released to patient charts and re-disenabled them on (b)(6) 2023.The patient results that were released did not have reference ranges applied to them and 79 of the results were not flagged for low iron.No impact to patient management was reported.
Additional Manufacturer Narrative
The abbott specialist determined that the cause of the incorrectly released results by the aliniq ams was due to human error when the wrong configurations were performed during an assay verification phase.To address the scenario the tests were disabled in the aliniq ams automation monitor.Additionally, the resolution was to undo the implemented change in the driver parameter and properly configure the ¿assay availability¿ in the instrument transmission settings.A review of tracking and trending of the aliniq found no additional complaints 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 no systemic issue or deficiency with the aliniq ams was identified.After further review, section h6 component code was updated from (b)(6).
Event or Problem Description
The customer reported that during aliniq ams configuration by abbott, 379 iron and hdl results were released incorrectly before verification and lims build was completed.All the assays were disabled in the ams automation as required to prevent results from being generated in a live state.However, an ams specialist enabled the assays on (b)(6) 2023, and the customer found the results were then being released to patient charts and re-disenabled them on (b)(6) 2023.The patient results that were released did not have reference ranges applied to them and 79 of the results were not flagged for low iron.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16750961
• Report Number: 3004032053-2023-00013
• Device Sequence Number: 19649560
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/14/2023

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: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2020
• 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