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

Catalog Number 04P77-25

Device Problem False Positive Result (1227)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The customer observed false reactive architect hbsag next confirmatory and architect hbsag next qualitative results for four cadaveric samples.The following data was provided (c2 >/=0.70 s/co and >/=50%neutralization is confirmed positive): sample id 2239577083 c1 result was 0.38 s/co, c2 result was 1.36 s/co, %neutralization was 91%.The sample was tested with the architect hbsag next assay, and the results were 86.55 and 1.76 s/co, which is reactive.The patient¿s pre-mortem hbsag result was 0.14 s/co, which is nonreactive.Sample id 2246943026 c1 result was 4.86 s/co, c2 result was 92.07 s/co, %neutralization was 92%.The sample was tested with the architect hbsag next assay, and the results were 223.37 and 178.36 s/co, which is reactive.The patient¿s pre-mortem hbsag result was 0.16 s/co, which is nonreactive.Sample id 2249556550 c1 result was 0.53 s/co, c2 result was 0.84 s/co, %neutralization was 55%.The sample was tested with the architect hbsag next assay, and the results were 1.18 and 10.61 s/co, which is reactive.The patient¿s pre-mortem hbsag result was nonreactive.Sample id 2248891476 c1 result was 0.51 s/co, c2 result was 4.09 s/co, %neutralization was 94%.The sample was tested with the architect hbsag next assay, and the results were 6.86 and 8.66 s/co, which is reactive.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id: 2239577083, sample id: 2246943026, sample id: 2249556550, and sample id:2248891476 all available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 04p77-25, that has a similar product distributed in the us, list number 4p77-27.

Manufacturer Narrative

The complaint investigation for false reactive architect hbsag next qualitative and architect hbsag next confirmatory results included a search for similar complaints, review of complaint text, trending data, labeling, device history records, and testing of a retained reagent kits of the complaint lot numbers.Return testing was not completed as returns were not available.Specificity testing was performed using an in-house retained kits of architect hbsag next qualitative reagent lot 43304fn00 and architect hbsag next confirmatory reagent lot 45553fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.No information was provided relating to sample collection or sample storage.Trending review determined no related trend for the issue for the product.Device history record review of architect hbsag next qualitative reagent lot 43304fn00 and architect hbsag next confirmatory reagent lot 45553fn00 did not show any non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Product labeling provides information in relation to preparation for analysis and storage conditions for cadaveric samples.For cadaveric specimens if the specimens are not processed directly after initial centrifugation, it is recommended to remove the supernatant from the clot, red blood cells or separator gel until further processing.Performance has been established for the use of cadaveric blood specimens (specimens collected postmortem, non-heart-beating) that have been collected up to 24 hours after death.Based on the investigation, no systemic issue or deficiency of the architect hbsag next qualitative reagent lot 43304fn00 and architect hbsag next confirmatory reagent lot 45553fn00, was identified.

Event Description

The customer observed false reactive architect hbsag next confirmatory and architect hbsag next qualitative results for four cadaveric samples.The following data was provided (c2 >/=0.70 s/co and >/=50% neutralization is confirmed positive): sample id (b)(6) c1 result was 0.38 s/co, c2 result was 1.36 s/co, % neutralization was 91%.The sample was tested with the architect hbsag next assay, and the results were 86.55 and 1.76 s/co, which is reactive.The patient¿s pre-mortem hbsag result was 0.14 s/co, which is nonreactive.Sample id (b)(6) c1 result was 4.86 s/co, c2 result was 92.07 s/co, % neutralization was 92%.The sample was tested with the architect hbsag next assay, and the results were 223.37 and 178.36 s/co, which is reactive.The patient¿s pre-mortem hbsag result was 0.16 s/co, which is nonreactive.Sample id (b)(6) c1 result was 0.53 s/co, c2 result was 0.84 s/co, % neutralization was 55%.The sample was tested with the architect hbsag next assay, and the results were 1.18 and 10.61 s/co, which is reactive.The patient¿s pre-mortem hbsag result was nonreactive.Sample id (b)(6) c1 result was 0.51 s/co, c2 result was 4.09 s/co, % neutralization was 94%.The sample was tested with the architect hbsag next assay, and the results were 6.86 and 8.66 s/co, which is reactive.There was no impact to patient management reported.

• Brand Name: ARCHITECT HBSAG NEXT CONFIRMATORY 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: 17131560
• MDR Text Key: 317267236
• Report Number: 3008344661-2023-00108
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/04/2023

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 Expiration Date: 01/21/2024
• Device Catalogue Number: 04P77-25
• Device Lot Number: 45553FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC HBSAG QUAL RGT KIT, 04P76-35, 43304FN00; ARC HBSAG QUAL RGT KIT, 04P76-35, 43304FN00; ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)