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 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

Complete information for patient identifier: multiple= (b)(6).All available patient information was included, no additional patient information was available.During an investigation, it was noted that the potential exists for the assay quality control requirement to be bypassed for the first use of an alinity s hbsag confirmatory reagent kit, (ln 06p03).This event can occur if the qc run includes the alinity s hbsag reagent kit (ln 06p02), the qc run is already in progress, a newly introduced alinity s hbsag confirmatory reagent kit is loaded onto the reagent carousel, and the alinity s hbsag screening assay calibration status has transitioned to qc in process.This issue has the potential to occur when operating with the alinity s system software versions 2.8.0 and prior.A product correction letter fa 28apr2022 has been distributed to the customers to notify them of the issue and provide the immediate necessary actions to follow until the mandatory upgrade of alinity s system software version 2.8.1 can be installed.Abbott is released alinity s system software version 2.8.1 (ln 04u76-16) to correct the issue.

Event Description

The customer reported that alinity s hbsag confirmatory assay results were generated for seven (7) sample ids without valid assay controls on (b)(6) 2023.This incident occurred on the alinity s system, serial number (b)(4) with software version 2.8.0.The customer provided the following results.Sid (b)(6): c1= 1.81 s/co (c1=> or =0.70 s/co and neutralization > or =50%=confirmed positive); c2=0.30 s/co (< 1.00 s/co=nonreactive)/neutralizing confirmatory= 92.31%.Sid (b)(6): c1=3.81 s/co ; c2=0.34 s/co ; neutralizing confirmatory=95.59%.Sid (b)(6): c1=1.33 s/co ; c2=0.38 s/co ; neutralizing confirmatory=81.84 %.Sid (b)(6): c1=1.08 s/co ; c2=0.37 s/co ; neutralizing confirmatory=78.93 %.Sid (b)(6): c1=1.56 s/co ; c2=1.67 s/co; neutralizing confirmatory=7.47 % (not confirmed).Sid (b)(6): c1=1866.26 s/co; c2= 0.48 s/co; neutralizing confirmatory= 99.98 %.Sid (b)(6): c1=1.82 s/co ; c2= 0.30 s/co; neutralizing confirmatory= 92.38%.No discrepant patient results were generated, and there was no reported impact to patient management.

• 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: 16372650
• MDR Text Key: 309600714
• Report Number: 1628664-2023-00001
• 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: BL_125674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-05/02/22-002-C
• Patient Sequence Number: 1
• Treatment: ALINITY S SW V2.8, 04U76-15, UNKNOWN; ALNTY S HBSAG CONF RGT, 06P03-59, UNKNOWN