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

Catalog Number	03R89-23
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that the aliniq ams (analyzer management system) spe rule is not blocking tests updated by qpl rules resulting in patient samples being reported incorrectly.The spe errors are causing incorrect results to be calculated and auto-validated.The error is causing qualitative interpretative results to be incorrectly calculated as qndet and then auto-validated.The customer provided the following two patient sid examples: (b)(6) and (b)(6).No specific patient data was provided.The customer requested that a rule be put in place to block all results on a sample when any test on the sample has an spe error.No impact to patient management was reported.
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.
Additional Manufacturer Narrative
The complaint investigation into the issue revealed that the aliniq ams spe (sample presentation errors) rule did not block tests updated by the quality programming language (qpl) rules.This allowed incorrect results to be calculated and auto validated.The issue was investigated by the aliniq ams technical team, and the technical group identified two scenarios in which the customer had configured a custom rule logic, which interacted unexpectedly with the existing standard error handling rule logic.This allowed serology samples with spe to be calculated and released.A resolution was proposed that involved adjusting the custom logic to keep the calculated results blocked for samples requiring presentation error handling.The device history record review did not identify any additional complaints for the current issue.Review of current labelling provides adequate information to the customer regarding the setup, configuration and management of test results and rules on the aliniq ams middleware (version 2.09).Trending review did not identify any trends.Based on the investigation, no malfunction or deficiency for the aliniq ams was identified.
Event or Problem Description
The customer stated that the aliniq ams (analyzer management system) spe rule is not blocking tests updated by qpl rules resulting in patient samples being reported incorrectly.The spe errors are causing incorrect results to be calculated and auto-validated.The error is causing qualitative interpretative results to be incorrectly calculated as qndet and then auto-validated.The customer provided the following two patient sid examples: (b)(6).No specific patient data was provided.The customer requested that a rule be put in place to block all results on a sample when any test on the sample has an spe error.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18369577
• Report Number: 3004032053-2023-00030
• Device Sequence Number: 7713066
• 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): 02/06/2024

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: 03R89-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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