MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	08P1021
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for patient identifier: sid (b(6) and sid (b(6).
Event or Problem Description
The customer observed false reactive alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory results for a pregnant female patient.The sample was pulled and repeated 4 days later with a nonreactive result.A second sample was drawn which generated a nonreactive result.The following data was provided: customer stated they had a sample that was drawn on (b)(6) 2023 that ran on (b)(6) 2023 and gave the following results according to customer: sid (b)(6) hbsag=1.04 hbsag confirmatory = reactive.Repeat of sample on (b)(6) 2023 sample was respun and reran in duplicate according to customer: hbsag=1.19 ; hbsag=1.27 ; hbsag confirmatory = 1.11 confirmed positive.Sample was rerun on (b)(6) 2023 result = sid (b)(6) hbsag=0.33 nonreactive.New sample drawn (b)(6) 2023 sid= (b)(6) hbsag = nonreactive hbsag confirmatory = negative per alinity i hbsag qualitative ii package insert < 1.00 nonreactive no retest required.= 1.00 reactive retest in duplicate no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included review of data and information provided by the customer, search for similar complaints, ticket and trending review, labeling review, device history review, and inhouse testing of retained reagent lot 43520fn00.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of false reactive results.The ticket and trending review for the complaint list number did not identify any trends.Device history review in did not identify any non conformances or deviations associated with complaint lots and the customer¿s issue.Performance testing was performed using an in-house retained kit of complaint lots.Acceptance criteria was met indicating the lots are performing as expected.A review of the labeling adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent, lot 43520fn00 was identified.

• Brand Name: ALINITY I HBSAG QUALITATIVE II REAGENT KIT
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16402197
• Report Number: 3008344661-2023-00041
• Device Sequence Number: 3327689
• Product Code: LOM
• UDI-Device Identifier: 00380740136581
• UDI-Public: 00380740136581
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Expiration Date: 05/06/2023
• Device Model Number: 08P1021
• Device Catalogue Number: 08P10-21
• Device Lot Number: 43520FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, AI21326.; ALNTY I PROCESSING MODU, 03R65-01, AI21326.
• Patient Sex: Female