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 02G22-25

Device Problem False Negative Result (1225)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

A literature article by leontari, maria, et al, ¿occult hepatitis b virus infection among blood donors in northwestern greece¿, journal of hepatology 2023, vol 78(s1), s922-s923, documented false nonreactive architect hbsag qualitative ii results on two donors.The study noted serum from patients who were hbsag (-)/anti-hbc (+) was further tested by polymerase chain reaction (pcr) for the detection of hbv-dna.In cases of occult hepatitis b virun infection (obi), sequencing and mutation analysis of the hbv pre-s/s gene were performed.For two cases of occult hepatitis b virus (hbv) infection (obi), the architect hbsag qualitative ii results were nonreactive but both had high hbv-dna levels (>200,000 iu/ml).Sequencing demonstrated s- and pre-s mutations.No impact to patient management was reported.

Manufacturer Narrative

Section e1 - address 1: complete address is (b)(6).This report is being filed on an international product, list number 02g22-25 (architect hbsag qualitative ii) 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

A literature article by leontari, maria, et al, ¿occult hepatitis b virus infection among blood donors in northwestern greece¿, journal of hepatology 2023, vol 78(s1), s922-s923, documented false nonreactive architect hbsag qualitative ii results on two donors.The study noted serum from patients who were hbsag (-)/anti-hbc (+) was further tested by polymerase chain reaction (pcr) for the detection of hbv-dna.In cases of occult hepatitis b virun infection (obi), sequencing and mutation analysis of the hbv pre-s/s gene were performed.For two cases of occult hepatitis b virus (hbv) infection (obi), the architect hbsag qualitative ii results were nonreactive but both had high hbv-dna levels (>200,000 iu/ml).Sequencing demonstrated s- and pre-s mutations.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation false nonreactive architect hbsag qualitative ii results included a review of data and information from the article ¿occult hepatitis b virus infection among blood donors in northwestern greece¿, ticket trending review, device history record review, field data review, labeling review, and literature review.Return testing was not completed as returns were not available.Data and information provided in the article were reviewed and support the complaint issue.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 product list number and complaint issue.The overall performance of the architect hbsag qualitative ii reagent was reviewed using data gathered from customers worldwide.Sine the likely cause lot is unknown, the review of the within date lots with at least 2000 patient results showed that all median values are within ±3sd of the mean indicating that the lots are comparable and performing acceptably in the field.Labeling was reviewed and sufficiently addresses the customer's issue.Per product labelling, hbv is subject to a mutation rate 10 times higher than the mutation rate of other dna viruses.Some of these mutations may cause changes in the antigenic structure of hbsag, resulting in epitopes that are no longer recognized by anti-hbs.Hbsag mutations may result in a less favorable outcome in some patients and false negative results in some hbsag assays.A group of patients with chronic hbv infection has been identified by sensitive, molecular testing for hbv dna.Members of this group are often referred to as having occult hepatitis b virus (hbv) infection which is diagnosed when an hbv dna test is positive but hepatitis b surface antigen (hbsag) is undetectable.Occult hepatitis b infection (obi) occurs in a number of clinical settings and may represent: (i) acute infection in the window period, (ii) hbv tailend of chronic hbv infection, (iii) persistence of replication at low level after recovery in the presence of anti-hbs, or (iv) occurrence of an escape mutant in vaccinated or unvaccinated individuals not detected by current hbsag assays.(references:(b)(6).Vox sanguinis (2008) 94, 153¿166 and (b)(6) dis 2002; 2: 479¿86).Based on this investigation, no systemic issue or deficiency was identified with the architect hbsag qualitative ii reagent, lot number unknown.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17825287
• MDR Text Key: 324363803
• Report Number: 3008344661-2023-00171
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 10/13/2023

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: 02G22-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/13/2023
• 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 I1000SR MOD, 01L86-01, 117UNKNOWND11; ARC I1000SR MOD, 01L86-01, 117UNKNOWND11