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

Catalog Number 08P08-22

Device Problem False Negative Result (1225)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08p08, that has a similar product distributed in the us, list number 04p53.

Event Description

The customer observed a false nonreactive alinity i hbsag result for a dialysis patient, who is tested every 6 months.The following data was provided (<0.05 iu/ml is nonreactive, >/=0.05 iu/ml is reactive): result in october 2023 was 0.00 iu/ml.The patient had a blood transfusion in november 2023 and blood drawn after the transfusion was tested with a cleia method hbsag and the result was 0.024, which is positive.The sample from october 2023 was tested with a cleia method hbc (igg) and the result was 2.2, which is positive and the anti-hbs result was 10.0, which is positive.The sample from october 2023 was also tested with an alinity i hbc and the result was 1.44 s/co and an alinity i anti-hbs and the result was 4.2 miu/ml.There was no impact to patient management reported.

Event Description

The customer observed a false nonreactive alinity i hbsag result for a dialysis patient, who is tested every 6 months.The following data was provided (<0.05 iu/ml is nonreactive, >/=0.05 iu/ml is reactive): result in (b)(6) 2023 was 0.00 iu/ml.The patient had a blood transfusion in november 2023 and blood drawn after the transfusion was tested with a cleia method hbsag and the result was 0.024, which is positive.The sample from october 2023 was tested with a cleia method hbc (igg) and the result was 2.2, which is positive and the anti-hbs result was 10.0, which is positive.The sample from (b)(6) 2023 was also tested with an alinity i hbc and the result was 1.44 s/co and an alinity i anti-hbs and the result was 4.2 miu/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a false nonreactive alinity i hbsag result included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending review determined no related trend for the issue for the product.Device history record review did not identify any related non-conformances or deviations with the likely cause lot and complaint issue.The overall performance of alinity i syphilis tp reagents in the field was reviewed using data gathered from customers worldwide.A review of field data for the alinity i hbsag assay shows that the median patient result for lot 49355fn00 falls within established baseline, indicating the reagent lot is performing acceptably on market, and confirms no systemic issue for the lot.Labeling was reviewed and found to adequately address the issue under review.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or product deficiency of alinity i hbsag, lot number 49355fn00, was identified.

• Brand Name: ALINITY I HBSAG REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE 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: 18915098
• MDR Text Key: 337858632
• Report Number: 3008344661-2024-00036
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Catalogue Number: 08P08-22
• Device Lot Number: 49355FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2023
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)