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  

Event Description

The eye bank association of america (ebaa) reported an increase of false reactive alinity s hbsag results for multiple cadaveric (non-heart beating) samples received from the testing laboratories starting in 2023.It is unknown which testing laboratories performed the alinity s hbsag testing.Ebaa reported around 11.3% of tissue was discarded and not released for transplant.Also, it was observed that there were discordant serologic test results between a pre-screening result versus the alinity s result used for donor/tissue eligibility or screening assays.There was no additional impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This incident has been linked to a previously reported incident: mrf reports #'s 3008344661-2024-00043 and 3008344661-2024-00044.

Manufacturer Narrative

The complaint investigation included a review of data and information provided, a search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.Data and information provided were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity.Ticket trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with list number 06p02-60 and the complaint issue.Labeling was reviewed and adequately addresses the issue under review.A technical review of customer release test data and statistical process control charts for alinity s 6p02-60 reagent lots was performed.No issues were identified during review of customer release testing and there were no issues identified regarding the performance of hbsag lots manufactured over the time frame.A review of field data for alinity s hbsag was performed.Alinity s hbsag list number 6p02-60 lots across the transplant peer group 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 all list number 6p02-60 tested lots is within product requirements and comparable to other list number 6p02-60 lots analyzed in the comparison.Within the transplant peer group, the specificity performance of all list number 6p02-60 lots with greater than 55 test points are within the package insert representative data confidence interval for cadaveric specimens.Donor demographics (older age) and comorbidities, as well as sample integrity have been identified as contributing factors for false reactive results associated with cadaveric testing on the alinity s system.Abbott met with ebaa to reinforce the importance of applying pre-analytics best practices and ways in which abbott and ebaa could collaborate to broadly distribute this information to the ebaa board leadership, members, and their associated collection/specimen processing teams.Based on the information within the complaint record, no systemic issue or deficiency with the alinity s hbsag reagent was identified.

Event Description

The eye bank association of america (ebaa) reported an increase of false reactive alinity s hbsag results for multiple cadaveric (non-heart beating) samples received from the testing laboratories starting in 2023.It is unknown which testing laboratories performed the alinity s hbsag testing.Ebaa reported around 11.3% of tissue was discarded and not released for transplant.Also, it was observed that there were discordant serologic test results between a pre-screening result versus the alinity s result used for donor/tissue eligibility or screening assays.There was no additional impact to patient management reported.

• 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: 19123951
• MDR Text Key: 340371144
• Report Number: 3008344661-2024-00045
• Device Sequence Number: 1
• Product Code: QHM
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1