MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number 06P16-01

Device Problems Computer Software Problem (1112); False Positive Result (1227)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information for section d11: concomitant products- alinity s system software versions: alinity s sw version 2.8.1 (list number 04u76-16).Alinity s sw version 2.8.2 (list number 04u76-17).The investigation into issue 1 identified that the issue occurred as a result of human error caused by the field service engineer (fse) failing to perform all steps associated with maintenance and diagnostics (m&d) procedure 7140 sample pipettor las calibration (fse logon).It was noted that sample 2 pipettor was aspirating from a wrong position due to an incomplete calibration during execution of the m&d procedure.Alinity s system software version 2.9.0 requires the use of a barcoded calibration tool by the abbott field service engineer (fse) when calibrating sample pipettors at the las aspiration positions during the m&d procedure 7140.The investigation into issue 2, identified that the pipettor hard stop homing can be inaccurate due to hardware failures that interfere with pipettor gantry (robot) movement.Any interference that causes additional drag on the pipettor gantry when homing can cause the home position to be inaccurate without user notification.Alinity s system software version 2.9.0 includes pipettor straightness and homing checks that will notify the user with a corresponding message code (5032, 5033, 5034) if a pipettor positioning check fails at run initialization.A product correction letter was issued on 16jan2024 to all alinity s system customers who have installed alinity s systems, notifying them of these 2 potential issues that may be exhibited when operating the alinity s system with software versions prior to 2.9.0.The product correction letter informs the customer that an abbott representative will schedule a mandatory upgrade of their alinity s system to install software version 2.9.0 and provides the customer with the necessary actions to take until software version 2.9.0 is installed on their system.

Event Description

Abbott has identified two potential issues that may occur when operating the alinity s system with software versions 2.8.2 (list number 04u76-17) and prior.The following issues have been identified: 1) misassigned sample pipettor aspiration locations at the laboratory automation system (las) can cause results to be wrongly attributed to the incorrect unique sample identifier (sid).An incorrect las aspiration location calibration can cause misassigned test results, i.E., the result assigned to the sid originated from another sid onboard the instrument.This issue only impacts the alinity s systems which are integrated with a las.2) the pipettor positioning may be off target if a pipettor probe is not straight or homed correctly due to unintended contact between the pipettor or pipettor probe with another component during instrument operation.Sample pipettor probe positioning that is skewed 1.5 ¿ 2.0mm can cause inaccurate pipetting without generating a robotics and sensor message code (5000-5999).A bent or mispositioned sample pipettor probe off target 1.5 -2.0mm has the potential to affect pipetting accuracy and generate false positive results.Pipettor probe positioning off target more than 2.0mm will result in a message code being generated (hardware failure) and tests will be sent to exception.Test results are not impacted by mispositioned pipettor probes that may be off target less than 1.5mm.There was no reported impact to patient management as a result of either of these issues.Abbott is releasing alinity s system software version 2.9.0 (list number 04u76-18) to prevent these potential issues from occurring and improve the overall system.

• Brand Name: ALINITY S SYSTEM
• Type of Device: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18608288
• MDR Text Key: 334496979
• Report Number: 1628664-2024-00001
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-01/26/2024-001-C
• Patient Sequence Number: 1