MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG REAGENT KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)

Catalog Number	06P02-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive alinity s hbsag and alinity s hbsag confirmatory results generated for a donor sample.The following data was provided: (b)(6) 2023.Sample id (b)(6).Initial result = 1.80 s/co, repeated twice and results = 1.69 s/co and 1.68 s/co, repeated with an alternate method and result = non-reactive.(b)(6) 2023 alinity s hbsag confirmatory test was performed on analyzer with serial number (b)(6), and generated positive result: %n = 87.64%.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s hbsag results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Trending review determined no related trend for the issue and the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the likely cause lot and complaint issue.The overall reactive rates of lot 49017fn00, across qualtex laboratories (usa), applicable peer sites, and across a whole blood and plasma screening monitoring group were collected and assessed.In all groups and across all lots assessed the initial ¿ repeat reactive rate (%) = 0.29 product requirement and the blood screening product requirement values (% specificity (assuming 0 prevalence) = 99.5% are met.The complaint lot performs similarly as other lots in the field across all groups assessed.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the alinity s hbsag reagent, lot number 49017fn00.
Event or Problem Description
The customer observed false reactive alinity s hbsag and alinity s hbsag confirmatory results generated for a donor sample.The following data was provided: 29jun2023 sample id (b)(6) initial result = 1.80 s/co, repeated twice and results = 1.69 s/co and 1.68 s/co, repeated with an alternate method and result = non-reactive.30jun2023 alinity s hbsag confirmatory test was performed on analyzer with serial number as1225, and generated positive result: %n = 87.64%.No impact to patient management was reported.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Common Device Name: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; 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: 17413973
• Report Number: 3008344661-2023-00135
• Device Sequence Number: 15237666
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 01/11/2024
• Device Catalogue Number: 06P02-60
• Device Lot Number: 49017FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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 S HBSAG CONF RGT, 06P03-59, 47185FN00; ALNTY S HBSAG CONF RGT, 06P03-59, 47185FN00; ALNTY S SYSTEM, 06P16-01, AS1266; ALNTY S SYSTEM, 06P16-01, AS1266
• Patient Sex: Unknown