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 08P08-78

Device Problems False Negative Result (1225); Low Test Results (2458)

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

Event Date 04/23/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity i hbsag results on a 79-year-old male patient from the intervention/vascular surgery department.The sample was recentrifuged and repeated on another instrument which generated the same result.The patient was further tested and hbv dna was positive.The following data was provided: initial hbsag result = 0.00 iu/ml (nonreactive) other test results provided: anti-hbs = 175.98 iu/l; hbeag = 10.783 s/co; anti-hbe = 0.23s/co; anti-hbc = 9.6 s/co repeat hbsag result (another instrument) = 0.00 iu/ml (nonreactive) other test results provided: anti-hbs = 193.48 iu/l; hbeag = 7.92 s/co; anti-hbe = 0.83s/co; anti-hbc = 9.49 s/co hbv dna result = 2.07e+03 (positive) no impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, alinity i hbsag, list number 08p08-78, that has a similar product distributed in the us, architect hbsag, list number 04p53.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity i hbsag results on a 79-year-old male patient from the intervention/vascular surgery department.The sample was recentrifuged and repeated on another instrument which generated the same result.The patient was further tested and hbv dna was positive.The following data was provided: initial hbsag result = 0.00 iu/ml (nonreactive).Other test results provided: anti-hbs = 175.98 iu/l; hbeag = 10.783 s/co; anti-hbe = 0.23s/co; anti-hbc = 9.6 s/co.Repeat hbsag result (another instrument) = 0.00 iu/ml (nonreactive).Other test results provided: anti-hbs = 193.48 iu/l; hbeag = 7.92 s/co; anti-hbe = 0.83s/co; anti-hbc = 9.49 s/co.Hbv dna result = 2.07e+03 (positive).No impact to patient management was reported.

Manufacturer Narrative

Section d10 concomitant product was updated to include alinity i processing module serial number (b)(6).The complaint investigation for false nonreactive alinity i 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, in-house sensitivity testing, and literature review.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.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 43168fn00 and the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.This could potentially be a case of occult hepatitis b virus (hbv) infection which is diagnosed when an hbv dna test is positive but hepatitis b surface antigen (hbsag) is undetectable.Review of the publications, h.W.Reesink et al., ¿occult hepatitis b infection in blood donors¿, vox sanguinis (2008) 94 , 153¿166 and michael torbenson et al., ¿occult hepatitis b¿, lancet infect dis 2002; 2: 479¿86, occult hbv infection (obi) may represent acute infection in the window period, hbv tailend of chronic hbv infection, persistence of replication at low level after recovery in the presence of anti-hbs, or occurrence of an escape mutant in vaccinated or unvaccinated individuals not detected by current hbsag assays.Based on our investigation, no systemic issue or deficiency was identified with the alinity i hbsag reagent for lot 43168fn00.

Manufacturer Narrative

Correction to section h6: medical device problem code: corrected from (b)(6).

Manufacturer Narrative

Correction to section d10- concomitant product: this follow-up is being submitted to include the 2nd concomitant product that was not included in the last supplemental report.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16923271
• MDR Text Key: 315561899
• Report Number: 3008344661-2023-00090
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: LOM
• 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,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Catalogue Number: 08P08-78
• Device Lot Number: 43168FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 79 YR
• Patient Sex: Male