MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG CONFIRMATORY V.1 REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08P09-22

Device Problem False Positive Result (1227)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

The customer reported false reactive alinity i hbsag confirmatory and provided the following data for sample id (b)(6): initial result was 0.07 iu/ml and repeat result was 0.12 iu/ml (reference: = 0.05 iu/ml is reactive) the hbsag neutralization testing was confirmed positive and generated the following results: pretreatment 1 result was 0.50 s/co with a rlu of 397 and pretreatment 2 result was 1.35 s/co with a rlu of 1063 and the neutralization rate is (b)(4).Hbsag result tested on another analyzer (sn: (b)(6)) and generated a negative result of 0.00iu/m and confirmatory testing generated a negative result with 1:500 dilution on the original analyzer (sn: (b)(6)).Patient information: 61-year-old female with a negative hbsag testing history.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 08p09-22 and there is a similar product distributed in the us, list number 4p54.A1 patient identifier: complete sample id is (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive alinity i hbsag confirmatory and provided the following data for sample id (b)(6): initial result was 0.07 iu/ml and repeat result was 0.12 iu/ml (reference: = 0.05 iu/ml is reactive) the hbsag neutralization testing was confirmed positive and generated the following results: pretreatment 1 result was 0.50 s/co with a rlu of 397 and pretreatment 2 result was 1.35 s/co with a rlu of 1063 and the neutralization rate is (b)(6).Hbsag result tested on another analyzer (sn: ai23204) and generated a negative result of 0.00iu/m and confirmatory testing generated a negative result with 1:500 dilution on the original analyzer (sn: (b)(6)).Patient information: 61-year-old female with a negative hbsag testing history.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Return testing was not completed as specimens were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any related nonconformances or deviations associated with the complaint lot and customer reported issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.The review of ticket and trending did not identify any trends.Additionally, in-house testing was conducted for complaint lot 51482fn00, which concluded testing met acceptance criteria indicating the lot is performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity i hbsag confirmatory reagent lot 51482fn00.

• Brand Name: ALINITY I HBSAG CONFIRMATORY V.1 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: 18841238
• MDR Text Key: 337070905
• Report Number: 3008344661-2024-00032
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/04/2024

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: 04/12/2024
• Device Catalogue Number: 08P09-22
• Device Lot Number: 51482FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBSAG QUANT 120, 08P08-32, 53544FN00; ALNTY I HBSAG QUANT 120, 08P08-32, 53544FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 61 YR
• Patient Sex: Female