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

Catalog Number 08P11-22

Device Problem False Positive Result (1227)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

The customer observed false reactive alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory results for a 52-year-old male patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result was 108.66, repeat was 94.72 s/co.The sample confirmatory initial result was 88.30 s/co and 99.8318 %neut.The sample was repeated with the confirmatory assay and the result was 0.36 s/co and na %neut.The patient¿s previous testing on (b)(6) 2023 was 0.61 s/co.The patient had other testing done which was not questioned by the customer.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 = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08p11-22, that has a similar product distributed in the us, list number 08p11-21.

Manufacturer Narrative

The complaint investigation for false reactive alinity i hbsag qualitative ii results included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.The customer observed a false reactive result for one patient when using alinity i hbsag qualitative ii reagent, lot 53621fn00, and false confirmed result using alinity i hbsag qualitative ii confirmatory reagent, lot 55628fn00.Return testing was not completed as returns were not available.Specificity testing was performed using an in-house retained kit of lot 55628fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Using worldwide data, a review of field data for the alinity i hbsag qualitative ii assay shows that the median patient result for lot 53621fn00 falls within established baseline, indicating the reagent lot is performing acceptably on market, and confirms no systemic issue for the lot.Trending review determined no related trend for the issue for the products.Device history record review of lots 53621fn00 and 55628fn00 did not show any non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag qualitative ii assay, lot number 53621fn00 or alinity i hbsag qualitative ii confirmatory assay, lot number 55628fn00, was identified.

Event Description

The customer observed false reactive alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory results for a 52-year-old male patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6)initial result was 108.66, repeat was 94.72 s/co.The sample confirmatory initial result was 88.30 s/co and 99.8318 %neut.The sample was repeated with the confirmatory assay and the result was 0.36 s/co and na %neut.The patient¿s previous testing on 20oct2023 was 0.61 s/co.The patient had other testing done which was not questioned by the customer.There was no impact to patient management reported.

• Brand Name: ALINITY I HBSAG QUALITATIVE II 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18507944
• MDR Text Key: 333343304
• Report Number: 3008344661-2024-00009
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/13/2024

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 Catalogue Number: 08P11-22
• Device Lot Number: 55628FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBSAG QUAL 1200, 08P10-32, 53621FN00; ALNTY I HBSAG QUAL 1200, 08P10-32, 53621FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 52 YR
• Patient Sex: Male