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

Catalog Number 02G22-30

Device Problem False Negative Result (1225)

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

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.This report is being filed on an international product, architect hbsag qualitative ii, list number 02g22-30, that has a similar product distributed in the us, 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 architect hbsag qualitative ii results for a female dialysis patient.The patient samples were processed on the architect i2000 processing module from the year 2018 to march 2021.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 is reactive): sample id (b)(6), on (b)(6) 2018, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6), on (b)(6) 2018, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6), on (b)(6) 2018, architect hbsag qualitative ii result was 0.3 s/co.Sample id (b)(6), on (b)(6) 2019, architect hbsag qualitative ii result was 0.3 s/co.Sample id (b)(6), on (b)(6) 2020, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6), on (b)(6) 2021, architect hbsag qualitative ii result was 0.4 s/co.The patient was tested on the siemens platform multiple times which also generated negative results.The customer provided the following viral load test results: (b)(6) 2022 result = 168.(b)(6) 2023 result = 621.(b)(6) 2023 result = 2031.(b)(6) 2023 result = 1761.(b)(6) 2023 result = 3345.(b)(6) 2023 result = 1861.(b)(6) 2023 result = 872.(b)(6) 2023 result = 1272.(b)(6) 2023 result = 1352.(b)(6) 2023 result = 1618.(b)(6) 2023 result = 570.(b)(6) 2023 result = 3221.(b)(6) 2023 result = 4089.(b)(6) 2023 result = 3023.The virus was sequenced, and it showed: sequence and phylogenetic analysis across the hbsag region indicated that the virus isolated from this sample belongs to genotype b2.Please note that additional analysis showed the presence of the following amino acid changes: p127p/t, t131n, s132y, m133t and f134f/v.Amino acid changes occurring at these codons may abrogate the hbsag conformation resulting in an alteration to hbsag antigenicity.The customer stated that the patient had not been treated for hepatitis b and that there was risk to staff and other patients as this patient was not being treated as a hepatitis b positive patient; however, the customer stated there were no transmissions.No additional impact to patient management was reported.

Manufacturer Narrative

The complaint investigation false nonreactive architect hbsag quantitative ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and literature review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed.The data contains results for the patient from june 2018 to june 2023.Review of the data confirms the patient returned nonreactive results for hbsag qualitative ii from june 2018 to april 2023.From november 2021, the customer tested the patient using additional hepatitis b serological markers including anti-hbc, hbeag, anti-hbe and anti-hbs where the patient was reactive for anti-hbc and anti-hbe, nonreactive for hbeag and nonprotective for anti-hbs.It is noted that the patient first returned a reactive anti-hbc result in november 2021 with further reactive anti-hbc results generated in february 2022, november 2022, february 2023, march 2023, may 2023 and june 2023.November 2021 is the earliest date where the patient tested nonreactive for hbsag qualitative ii and reactive for anti-hbc.Reactive anti-hbc results are an indication for a prior infection.Additionally, the patient¿s first viral load result was in november 2022 with viral load values increasing over subsequent months with the highest viral load value returned in june 2023.Per the complaint text, amino acid changes (p127p/t, t131n, s132y, m133t and f134f/v) were identified upon sequencing of the virus.Amino acid changes occurring at these codons may abrogate the hbsag conformation resulting in an alteration to hbsag antigenicity.Per hbsag qualitative ii product labeling, hbsag mutants have been reported in a wide range of patient populations, including renal dialysis patients.Hbsag mutations may result in a less favorable outcome in some patients and false negative results in some hbsag assays.It is important to note, that at low hbsag concentration levels, sample determination can vary across different available commercial assays due to sensitivity differentials and or mutant detection capabilities.In this case, the hbsag qualitative ii values obtained on architect between june 2018 and march 2021 ranged from 0.2 to 0.4 s/co.The hbsag qualitative ii values obtained on alinity between july 2021 and june 2022 ranged from 0.3 to 1.3 s/co.From november 2022, the patient had borderline nonreactive alinity i hbsag qualitative ii results suggesting hbsag may be present in the samples at very low concentrations with reactive alinity i hbsag qualitative ii results returned in may 2023 and june 2023.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 the list number and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Occult hbv infection is a known phenomenon and is diagnosed when a hbv dna test is positive but hbsag is undetected.Occult infection may represent acute infection in the window period, hbv tailend of chronic hbv infection, persistence of replication at low level after recovery or occurrence of an escape mutant in vaccinated or unvaccinated individuals not detected by current hbsag assays.(references: h.W.Reesink et al.Occult hepatitis b infection in blood donors.Vox sanguinis (2008) 94, 153¿166 and (b)(6).Occult hepatitis b.Lancet infect dis 2002; 2: 479¿86).The investigation determined that this adverse event represents abnormal use.In this case, the customer did not treat the patient based on the nonreactive hbsag qualitative ii results; however, the hepatitis panel results over the past two years have been indicative of occult infection and/or infection with a mutant strain.Based on this investigation, no systemic issue or deficiency was identified with the architect hbsag quantitative ii reagent, lot number unknown.

Event Description

The customer observed false nonreactive architect hbsag qualitative ii results for a female dialysis patient.The patient samples were processed on the architect i2000 processing module from the year 2018 to march 2021.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 is reactive): sample id (b)(6) , on 07jun2018, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6) , on 07aug2018, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6) , on 08aug2018, architect hbsag qualitative ii result was 0.3 s/co.Sample id (b)(6) , on 25jul2019, architect hbsag qualitative ii result was 0.3 s/co.Sample id (b)(6) , on 16jul2020, architect hbsag qualitative ii result was 0.2 s/co.Sample id (b)(6) , on 17mar2021, architect hbsag qualitative ii result was 0.4 s/co.The patient was tested on the siemens platform multiple times which also generated negative results.The customer provided the following viral load test results: 23nov2022 result = 168.22feb2023 result = 621.16mar2023 result = 2031.27mar2023 result = 1761.29mar2023 result = 3345.30mar2023 result = 1861.10apr2023 result = 872.25apr2023 result = 1272.04may2023 result = 1352.09may2023 result = 1618.24may2023 result = 570.05jun2023 result = 3221.09jun2023 result = 4089.23jun2023 result = 3023.The virus was sequenced, and it showed: sequence and phylogenetic analysis across the hbsag region indicated that the virus isolated from this sample belongs to genotype b2.Please note that additional analysis showed the presence of the following amino acid changes: p127p/t, t131n, s132y, m133t and f134f/v.Amino acid changes occurring at these codons may abrogate the hbsag conformation resulting in an alteration to hbsag antigenicity.The customer stated that the patient had not been treated for hepatitis b and that there was risk to staff and other patients as this patient was not being treated as a hepatitis b positive patient; however, the customer stated there were no transmissions.No additional impact to patient management was reported.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II 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: 17587793
• MDR Text Key: 321576378
• Report Number: 3008344661-2023-00160
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110029
• 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
• Report Date: 08/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 02G22-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female