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	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer observed false reactive alinity s hbsag results for a cadaveric sample.The following data was provided (>/=1.00 s/co is reactive): sample id (b)(6), 48-year-old male, initial result, on (b)(6) 2023, was 1.68, repeats were 1.36 and 1.46 s/co.The sample was negative when tested with nat.The associated tissues from this donor were discarded.There was no impact to patient management reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.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 or deviations with the likely cause lot number, 42375fn00, and complaint issue.The overall reactive rates of list number 06p02-60, lot 42375fn00, across core, applicable peer sites, and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group, the initial reactive rate (irr), repeat reactive rate (rrr), and specificity (assuming zero prevalence) observed for lot 42375fn00 is within product requirements, within package insert representative data, and comparable to other lots analyzed in the comparison: lot 42375fn00: (b)(4).Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s hbsag, lot number 42375fn00, is performing as intended and no systemic issue or deficiency was identified.

• 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: 17221745
• Report Number: 3008344661-2023-00120
• Device Sequence Number: 16899857
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2023
• Device Catalogue Number: 06P02-60
• Device Lot Number: 42375FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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 S SYSTEM, 06P16-01, AS1346.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 48 YR
• Patient Sex: Male