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

Model Number 08P1121

Device Problem False Positive Result (1227)

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

Event Date 01/28/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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).

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 in house testing of a retained reagent lot 42595fn00.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 positive results.The ticket and trending review for the complaint list number did not identify any trends.Device history review in did not identify any nonconformances or deviations associated with the complaint lot and the customer¿s issue.Performance testing was performed using an in-house retained kit of the complaint lot.Acceptance criteria was met indicating the lot is 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 confirmatory reagent, lot 42595fn00, was identified.

• Brand Name: ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT
• Type of Device: 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: 16402194
• MDR Text Key: 310348267
• Report Number: 3008344661-2023-00039
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00380740130459
• UDI-Public: 00380740130459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 08P1121
• Device Catalogue Number: 08P11-21
• Device Lot Number: 42595FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI21326; ALNTY I PROCESSING MODU, 03R65-01, AI21326