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

Model Number	03R89-23
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer experienced a delay in reporting patient results (hbcore and hcv-ii) due to the customer's lis not receiving data from the aliniq ams.It was discovered that the aliniq ams was unable to transfer the results because the cpu went out.Field service had to reset the ams server to resolve the issue.The customer stated that due to hcv-ii results being delayed approximately 24 hours, transfusion of blood product was delayed to one patient.It is unknown what type of blood product, patient diagnosis or whether there was any patient harm due to the delay.No additional patient details were available.
Additional Manufacturer Narrative
Data communication between the aliniq ams and the customer middleware and lis are performed via sftp file transfer that is managed by the laboratory it department.Technical investigations confirmed that all the samples were correctly received by the aliniq ams from the alinity s and they were properly managed by the aliniq ams on november 09, 2022.All test result files were sent from the aliniq ams to lis via labonlinelink (as the evidence of the correct transmission the result files were re-named from.Xxx to.Res).The root cause of the event was a customer use error: sftp communication failure occurred between november 09, 2022 12.49pm and (b)(6) 2022 at ~6pm in the customer environment where the customer it department is responsible for its infrastructure security and availability.Delays in data file transfer from the aliniq ams to lis was caused by acts or omissions of the laboratory it department.Being the customer it department is the owner of the environment and fully responsible to ensure infrastructure security and availability, actions to restore communications within the laboratory were taken by the customer it team.On (b)(6) 2022 the customer restarted their servers but they did not provide any details about actions or troubleshooting performed by their it department to restore system connections and data transfer.Therefore, as no issue was confirmed on the aliniq ams, no actions were taken on the aliniq ams product.The local abbott representative supported the customer in re-sending test results managed by the aliniq ams on 09 and (b)(6) 2022 and in the verification that all results were present and transferred to the lis.Trending review determined no trend for the issue for the product.No additional complaints similar to the issue described in the current complaint were identified.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no malfunction or deficiency for the aliniq ams was identified.

• 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: 15874719
• Report Number: 3004032053-2022-00010
• Device Sequence Number: 19465979
• Product Code: JQP
• UDI-Device Identifier: 00380740145118
• UDI-Public: 00380740145118
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03R89-23
• Device Catalogue Number: 03R89-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown