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

Catalog Number	03R89-62
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
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.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).
Event or Problem Description
The customer reported a wrong configuration of channel numbers with their aliniq ams software.The customer switched to newer versions of triglycerides, iron, and alkaline phosphatase assays which required the channel numbers for those assays to change.The new channel number provided for triglycerides was actually the channel number for digitoxine, so the samples that were to be tested with the triglyceride were actually tested with the digitoxine assay.There were 8 patient samples affected with sample ids ranging from (b)(6) and all results generated were <3.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for inconsistent triglycerides (trig) results released by the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.A review of labeling and historical data was done, and both were adequate, with no trends found.The inconsistency of test results between the middleware and the instruments (alinity c) was due to the incorrect data input received from the abbott application specialist and partial verification of the changed assays that led to an incorrect test-channel association in aliniq ams.Because of data provided by the abbott application specialist to the abbott informatic specialist, containing the list of the tests to be changed and related transaction codes, triglyceride assay test code the channel codes of the alinity analyzers were set up incorrectly in aliniq ams.The upload/download channels of the triglyceride (trig) test were misconfigured in aliniq ams with the digitoxine (digi) assay code causing the wrong association of the test results in aliniq ams.Incoherence of trig results were not discovered during the verification phase before the production as the test session on the new assays was focused only on the data transmission while the analyzer was still on maintenance for calibration.The issue was resolved through a configuration change within the aliniq ams middleware settings at the customer site: channel codes of the triglycerides test was properly associated in the analyzer section on the middleware.No inadequate patient treatments or adverse impacts on patients¿ health were reported by the customer due to this issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams middleware, version 3.01, was identified.
Event or Problem Description
The customer reported a wrong configuration of channel numbers with their aliniq ams software.The customer switched to newer versions of triglycerides, iron, and alkaline phosphatase assays which required the channel numbers for those assays to change.The new channel number provided for triglycerides was actually the channel number for digitoxine, so the samples that were to be tested with the triglyceride were actually tested with the digitoxine assay.There were 8 patient samples affected with sample ids ranging from (b)(6) and all results generated were 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: 17393355
• Report Number: 3004032053-2023-00019
• Device Sequence Number: 21061200
• 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): 08/04/2023

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 Catalogue Number: 03R89-62
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/04/2023
• 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
• Patient Sex: Unknown