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

Model Number	03R89-48
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section patient identification: sids (b)(6).Initial reporter name and address - phone complete entry = (b)(6).
Event or Problem Description
The customer observed the incorrect sample id number provided by the aliniq ams base software for a patient sample.Sample (b)(6) did not provide the expected aliquot sample.They received an aliquot with sample number (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
Section b5: additional information provided.
Event or Problem Description
Additional information received from the customer on 21mar2023.Sample id (b)(6) is the primary sid, and sample id (b)(6) is the aliquot sid.The customer observed an additional incorrect sample id number provided by the aliniq ams base software which was sample id (b)(6).
Additional Manufacturer Narrative
Additional information section h4 - device mfg date.During the investigation of the customer issue, a technical investigation was performed by the abbott subject matter expert (sme).Through the analysis of the issue, it was confirmed that a test (a_endoa) was part of the tests for two aliquots (aml_s and jes_s).If an aliquot code (aml_s/jes_s) is received by aliniq ams in the message sent by the lis, the middleware is supposed to check the presence of the test to be performed (a_endoa).When aliniq ams finds a_endoa it copies its sid and pastes it in the previous result of the aliquot test (ams_s/jes_s) and this is the last sid value that is used to print the label of the aliquot.A review of the smart rules editor (sre) module audit trail found that, on (b)(6) 2022, at 09:54am, the labonlinelink rule that manages dynamic aliquots on the track has been modified by the customer without informing abbott.The customer changed the configuration of the aliniq ams rule adding a test (a_endoa), already associated to an aliquot (aml_s) to another secondary tube (jes_s) in the template.Because of this (a_endoa) test addition to the aliquot (jes_s), the aliniq ams test workflow was duplicated and, when the second order jes_s for sid (b)(6) was received, it was overwritten to the order received for the other aliquot (aml_s, sid (b)(6)) assigning the previous one ((b)(6)) and causing the incorrect label of the aml_s aliquot sample.The issue was resolved through a configuration change within the labonlinelink rule template at the customer site performed by the abbott informatic specialist: a_endoa test was removed from the aml_s aliquot so that it could remain only in the jes_s secondary tube for the correct creation of that unique aliquot.A retrospective review of the affected patient samples was performed to identify those samples managed between (b)(6) 2022, and (b)(6) 2023, where aml_s and jes_s had the same previous test results.Through the review it was identified that 62 samples were found to be impacted by the issue.There has been no reported impact to patients¿ health, safety or treatment due to the customer issue.A review of complaints did not identify any related trends for the product for the issue.Review of the history record was also performed and did not identify any non-conformances or potential nonconformances associated with the complaint issue.Furthermore, labeling was reviewed and found to adequately address the issue under review.Based on the investigation, it was found that the incorrect template rule configuration that led to the incorrect sid assignment for secondary tubes was due to the customer changing the configuration.There was no deficiency or malfunction identified with the aliniq ams.H6 - adverse event problem: g code corrected from g03001 to g02008.
Event or Problem Description
The customer observed the incorrect sample id number provided by the aliniq ams base software for a patient sample.Sample (b)(6) did not provide the expected aliquot sample.They received an aliquot with sample number (b)(6).No impact to patient management was reported.Additional information received from the customer on 21mar2023.Sample id (b)(6) is the primary sid, and sample id (b)(6) is the aliquot sid.The customer observed an additional incorrect sample id number provided by the aliniq ams base software which was sample id (b)(6).

• 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: 16566670
• Report Number: 3004032053-2023-00011
• Device Sequence Number: 12152837
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 05/24/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 05/19/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/13/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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