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

Catalog Number 08P10-32

Device Problem False Negative Result (1225)

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

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Section a1: patient identifier complete entry.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number: 08p10-32, that has a similar product distributed in the us, list number: 08p10-31.The complaint investigation for false nonreactive alinity i hbsag qualitative ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.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 on (b)(6) 2021, with further reactive anti-hbc results generated on (b)(6) 2022, on (b)(6) 2023.On (b)(6) 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.From the data provided, the patient¿s first viral load result was on (b)(6) 2022 with viral load values increasing over subsequent months with the highest viral load value returned on (b)(6) 2023.Based on the investigation, it was 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.Return testing was not completed as returns were not available at this time.The overall performance of alinity i havab igg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The complaint lot number is unknown in this case; however, the review shows that lots are comparable and performing acceptably in the field.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 on (b)(6) 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 on (b)(6) 2023.Occult hbv infection is a known phenomenon and is diagnosed when an hbv dna test is positive but hbsag is undetected.Occult infection may represent acute infection in the window period, hbv tail end 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 michael torbenson and david l thomas.Occult hepatitis b.Lancet infect dis 2002; 2: 479¿86).Trending review determined no related trend for the issue for the product.Device history record review of the list number did not show any non-conformances or deviations.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 deficiency the alinity i hbsag qualitative ii assay, list number: 08p10-32, was identified.

Event Description

The customer observed false nonreactive alinity i hbsag qualitative ii results for a female dialysis patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 is reactive): sample id: (b)(6), on (b)(6) 2021, hbsag result was 0.3 s/co.Sample id: (b)(6), on (b)(6) 2021, hbsag result was 0.7 s/co.Sample id: (b)(6), on (b)(6) 2021, hbsag result was 0.6 s/co; additional laboratory results were provided for this sample: core result was 8.8, hbeag result was 0.3, anti-hbe was 0; anti-hbs was 0.1.Sample id: (b)(6), on (b)(6) 2022, hbsag result was 0.5 s/co; additional laboratory results were provided for this sample: core result was 9.7, hbeag result was 0.4, anti-hbe was 0.Sample id: (b)(6), on (b)(6) 2022, hbsag result was 0.7 s/co; additional laboratory results were provided for this sample: core result was 7.3, hbeag result was 0.4, anti-hbe was 0; viral load was 168.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.9 s/co; additional laboratory results were provided for this sample: core result was 7.2, hbeag result was 0.3, anti-hbe was 0; viral load was 621.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: core result was 7.7, hbeag result was 0.3, anti-hbe was 0.1; viral load was 2031.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.7 s/co; additional laboratory results were provided for this sample: anti-hbs result was 2; viral load was 872.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.6 s/co.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.6, anti-hbe was 0.1; viral load was 1352.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: viral load was 1618.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.5, anti-hbe was 0.1; anti-hbs was 1.1, viral load was 570.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 1.3 s/co; additional laboratory results were provided for this sample: viral load was 3221.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.6, anti-hbe was 0.1; anti-hbs was 0.9, viral load was 4089.Sample id: (b)(6), on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: viral load was 3023.It was noted that the patient was tested with a siemens assay and the results were also negative.The patient had additional viral load testing results provided on (b)(6) 2023 it was 1761, on (b)(6) 2023 it was 3345, on (b)(6) 2023 it was 1861, and on (b)(6) 2023 it was 1272.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.There was no additional impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i hbsag qualitative ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.From (b)(6) 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 (b)(6) 2021, with further reactive anti-hbc results generated in (b)(6) 2022, (b)(6) 2022, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023.(b)(6) 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.From the data provided, the patient¿s first viral load result was in (b)(6) 2022 with viral load values increasing over subsequent months with the highest viral load value returned in (b)(6) 2023.Based on the investigation, it was 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.Return testing was not completed as returns were not available at this time.The overall performance of alinity i hbsag qualitative ii reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The complaint lot number is unknown in this case; however, the review shows that lots are comparable and performing acceptably in the field.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 (b)(6) 2018 and (b)(6) 2021 ranged from 0.2 to 0.4 s/co.The hbsag qualitative ii values obtained on alinity between (b)(6) 2021 and (b)(6) 2022 ranged from 0.3 to 1.3 s/co.From (b)(6) 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 (b)(6) 2023 and (b)(6) 2023.Occult hbv infection is a known phenomenon and is diagnosed when an hbv dna test is positive but hbsag is undetected.Occult infection may represent acute infection in the window period, hbv tail end 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 michael torbenson and david l thomas.Occult hepatitis b.Lancet infect dis 2002; 2: 479¿86).Trending review determined no related trend for the issue for the product.Device history record review of the list number did not show any non-conformances or deviations.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 deficiency the alinity i hbsag qualitative ii assay, list number 08p10-32, was identified.Typographical error corrected in h10 from the overall performance of alinity i havab igg reagents to the overall performance of alinity i hbsag qualitative ii reagents.

Event Description

The customer observed false nonreactive alinity i hbsag qualitative ii results for a female dialysis patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 is reactive): sample id (b)(6), on (b)(6) 2021, hbsag result was 0.3 s/co.Sample id (b)(6), on (b)(6) 2021, hbsag result was 0.7 s/co.Sample id (b)(6), on (b)(6) 2021, hbsag result was 0.6 s/co; additional laboratory results were provided for this sample: core result was 8.8, hbeag result was 0.3, anti-hbe was 0; anti-hbs was 0.1 sample id (b)(6), on (b)(6) 2022, hbsag result was 0.5 s/co; additional laboratory results were provided for this sample: core result was 9.7, hbeag result was 0.4, anti-hbe was 0 sample id (b)(6), on (b)(6) 2022, hbsag result was 0.7 s/co; additional laboratory results were provided for this sample: core result was 7.3, hbeag result was 0.4, anti-hbe was 0; viral load was 168.Sample id (b)(6), on (b)(6) 2023, hbsag result was 0.9 s/co; additional laboratory results were provided for this sample: core result was 7.2, hbeag result was 0.3, anti-hbe was 0; viral load was 621.Sample id (b)(6), on (b)(6 )2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: core result was 7.7, hbeag result was 0.3, anti-hbe was 0.1; viral load was 2031.Sample id (b)(6), on (b)(6) 2023, hbsag result was 0.7 s/co; additional laboratory results were provided for this sample: anti-hbs result was 2; viral load was 872.Sample id (b)(6), on (b)(6) 2023, hbsag result was 0.6 s/co.Sample id (b)(6) , on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.6, anti-hbe was 0.1; viral load was 1352 sample id (b)(6) , on (b)(6) 2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: viral load was 1618.Sample id (b)(6) , on (b)(6) 2023, hbsag result was 0.8 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.5, anti-hbe was 0.1; anti-hbs was 1.1, viral load was 570.Sample id (b)(6) , on (b)(6) 2023, hbsag result was 1.3 s/co; additional laboratory results were provided for this sample: viral load was 3221.Sample id (b)(6) , on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: core result was 7.5, hbeag result was 0.6, anti-hbe was 0.1; anti-hbs was 0.9, viral load was 4089.Sample id (b)(6) , on (b)(6) 2023, hbsag result was 1.2 s/co; additional laboratory results were provided for this sample: viral load was 3023.It was noted that the patient was tested with a siemens assay and the results were also negative.The patient had additional viral load testing results provided on (b)(6) 2023 it was 1761, on (b)(6) 2023 it was 3345, on (b)(6) 2023 it was 1861, and on (b)(6) 2023 it was 1272.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.There was no additional impact to patient management reported.

• Brand Name: ALINITY I 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: 17607767
• MDR Text Key: 321805324
• Report Number: 3008344661-2023-00162
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P10-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female