MAUDE Adverse Event Report: ABBOTT IRELAND 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 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

Complete information patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) alinity i (b)(6) results for one patient.Sid (b)(6) generated an initial result of 0.38 s/co ((b)(6)) on sn (b)(4), anti-hbc was 0.12 s/co and (b)(6) was 0.45 miu/ml.The sample was measured again on sn (b)(4) in duplicate and the results were 1.13 and 1.25 s/co, the confirmation test was c2 0.7 and c1 0.32, which was confirmed with 83% for (b)(6).No impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer was reviewed and supports the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of false non-reactive results.Return testing was not performed as returns were not available.Device history record review was performed on lot 37383fn00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends related to the issue under review.Performance testing was performed using an in house retained kit of the complaint lot.All acceptance criteria were met indicating the lot is performing as expected.Labelling was reviewed which adequately addresses the current issue.It is possible that the non-reactive hbsag results obtained are due to sample integrity issues at the time of testing, however, occult hbv infection may also be a factor.The overall sensitivity of the alinity i hbsag qualitative ii assay was found to be 100% with a lower 95% confidence interval of 99.26%.Per product labelling, if the alinity i hbsag qualitative ii results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection.Based on all reviewed data, we conclude that there is no product deficiency with the alinity i hbsag qualitative ii reagent identified in this complaint.

• 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; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; 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: 14429748
• MDR Text Key: 291941533
• Report Number: 3008344661-2022-00050
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/21/2022

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: 02/11/2023
• Device Catalogue Number: 08P10-32
• Device Lot Number: 37383FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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)