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

Catalog Number 03R89-23

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 331293485
• Report Number: 3004032053-2023-00030
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1