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

Device Problem False Positive Result (1227)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false repeat reactive alinity s hbsag and htlv i/ii results for (b)(4) donors.The customer stated donors were tested with another method and negative results were obtained.The customer states they have had 10 repeat reactive hbsag(since (b)(6) 2024) and 2 repeat reactive htlv i/ii(in (b)(6) 2024) that were sent for confirmatory nat testing that was negative.The customer did not provide any specific result information.Additional information from 10apr2024: since the beginning of(b)(6), 5 more repeat reactive alinity s hbsag and 2 more repeat reactive htlv.There was no further result information provided or nonreactive result provided.All (b)(4) total samples were cadaveric and slightly hemolyzed.No impact to donor management was reported.

Event Description

The customer observed false repeat reactive alinity s hbsag and htlv i/ii results for 12 donors.The customer stated donors were tested with another method and negative results were obtained.The customer states they have had 10 repeat reactive hbsag(since jan2024) and 2 repeat reactive htlv i/ii(in march2024) that were sent for confirmatory nat testing that was negative.The customer did not provide any specific result information.Additional information from 10apr2024: since the beginning of april, 5 more repeat reactive alinity s hbsag and 2 more repeat reactive htlv.There was no further result information provided or nonreactive result provided.All 19 total samples were cadaveric and slightly hemolyzed.Additional information from 12apr2024: all hbsag reactive samples were rejected for tissue donations.For htlv reactive disposition status not provided.Htlv immunoblot results for the two additional samples from april were negative.Additional information from 15apr2024: the sample provided below are specific results/information from the testing in april.3 new hbsag positive samples are included that were ran on (b)(6) 2024, (b)(6) 2024, and 12aprl2024.The other 5 hbsag and 2 htlv are specific results provided from information provided (b)(6) 2024.(b)(6) 2024 hbsag sid (b)(6) initial result = 604.83 s/co repeat results = 609.94/629.86 tissue discarded donor had chronic hep b.Donor was nat, hep b core and hbsag positive.Repeat reactive that was confirmed reactive.(b)(6) 2024 hbsag sid (b)(6) initial result = 1.07 s/co repeat results = 0.97/1.07 nat negative tissue discarded (b)(6) 2024 hbsag sid (b)(6) initial result = 3.79 s/co repeat results = 3.41/3.47 nat negative discarded (b)(6) 2024 htlv sid (b)(6) initial result = 2.99 s/co repeat results = 4.22/2.71 immunoblot negative not provided if tissue was discarded.(b)(6) 2024 htlv sid (b)(6) initial result = 3.37 s/co repeat results = 3.65/3.28 immunoblot negative not provided if tissue was discarded.(b)(6) 2024 hbsag sid (b)(6) initial result = 1.35 s/co repeat results = 0.94/1.10 nat negative tissue discarded (b)(6) 2024 hbsag sid (b)(6) initial result = 1.45 s/co repeat results = 1.28/1.46 nat negative tissue discarded (b)(6) 2024 hbsag sid (b)(6) initial result = 1.63 s/co 1 repeat results =.69/1.69 nat negative not provided if tissue was discarded.(b)(6) 2024 hbsag sid (b)(6) initial result = 5.60 s/co repeat results = 3.41/3.76 nat negative not provided if tissue was discarded.(b)(6) 2024 hbsag sid (b)(6) initial result = 1.55 s/co repeat results = 1.64/1.67 nat negative not provided if tissue was discarded.Additional data provided 19apr2024: 2 cadaveric samples (b)(6) 2024 htlv sid (b)(6) initial result = 3.83 s/c repeat results = 4.68/4.48 nat negative not provided if tissue was discarded.(b)(6) 2024 htlv sid (b)(6) initial result = 1.87 s/co repeat results = 1.64/1.04 nat indeterminate not provided if tissue was discarded.No impact to donor management was reported.

Manufacturer Narrative

Complete information for section a1 patient identifier: sid¿s (b)(6) section b5 updated with additional patient information.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.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Evaluation of complaint data for the product and lot 58393fn00 did not identify an increase in complaint activity for the complaint issue.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 58393fn00 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.A review of field data for alinity s hbsag was performed.Overall reactive rates of lot 58393fn00 at core (usa), 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 performance of lot 58393fn00 is within product requirements and comparable to other lots analyzed in the comparison.At core (usa) the specificity performance of lot 58393fn00 is within package insert representative data for cadaveric specimens.Further evaluation of false reactive results associated with cadaveric testing on the alinity s system was previously completed.This review determined that donor demographics (older age) and comorbidities, as well as sample integrity were identified as contributing factors for the false reactive results.Customer education to highlight the importance of pre-analytics to optimize sample integrity were carried out.Based on the investigation alinity s hbsag reagent lot 58393fn00 is performing as intended, no systemic issue or deficiency of the alinity s hbsag reagent was identified.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Type of Device: 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19093622
• MDR Text Key: 340569183
• Report Number: 3008344661-2024-00044
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: (01)00380740136819(17)240826(10)58393FN00
• 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
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 06P02-60
• Device Lot Number: 58393FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)