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

Model Number 06P1601

Device Problem False Positive Result (1227)

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

Event Date 02/09/2022

Event Type  malfunction  

Event Description

The customer observed increment to initial reactive results for alinity s hiv ag/ab combo reagent while performing anti hcv ii assay installation on the alinity s system, sw v2.8.0.There were no false repeat reactive patient results were generated.No additional patient information was available.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information was included, no additional patient information was available.During the investigation, it was determined that the results were impacted by an error associated with the reagent probe (r1) wash cycle, which was introduced in the alinity s system software version 2.8.0, ln 04u76-15.The wash cycle removes fluid that remains on the interior and exterior surfaces of the probes at the wash station.With this error, the r1 probe washing is utilizing 1 ml versus the intended 3 ml of wash buffer to wash the exterior of the r1 probe.With this error, while operating on the alinity s system software version 2.8.0, ln 04u76-15, there is a potential for false reactive alinity s hiv ag/ab combo test results when alinity s hiv ag/ab combo reagent kit, ln 06p0155, and the alinity s anti-hcv ii reagent kit, ln 04w5655, are calibrated and run on the same processing lane.Abbott issued product correction letters to all customers who have an alinity s system installed.Customers who do not have alinity s anti-hcv ii assay commercially available have also been made aware of software issue.The letter states there have been no reports of falsely reactive results associated with this event for the assays available to them, and there is no potential for incorrect nonreactive results.The letter also informs them that a future software update will correct the issue.Note: the alinity s anti-hcv ii reagent kit is not currently available in the united states.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13589113
• MDR Text Key: 296378580
• Report Number: 1628664-2022-00020
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: BL_125674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06P1601
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-02/10/22-001-C
• Patient Sequence Number: 1
• Treatment: ALINITY S SW V2.8, 04U76-15, UNKNOWN