MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY S HBSAG REAGENT KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)

Catalog Number 06P02-55

Device Problem False Negative Result (1225)

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

Event Date 05/07/2022

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity s hbsag result for one donor.The following data were provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): (b)(6) 2022 sid (b)(6) result = 0.95 s/co (nonreactive).Hbsag by department of health, public health laboratory services (dh phls): positive grifols panther 2332 nat grifols end point pcr (procleix ultrio assays): positive other testing provided: hbv nat: reactive, hbv dna confirmation: positive for both qpcr and npcr (s-gene), anti-hbs by dh phls: <10 miu/ml, anti-hbc igm by dh phls: negative, anti-hbc total by dh phls: positive no impact to donor management was reported.

Manufacturer Narrative

Patient identifier: complete sid is (b)(6).The complaint investigation for false nonreactive alinity s hbsag result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, batch history record review, labeling review, and in-house testing of retained reagent kit.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances or deviations with lot 34457fn00.Batch history record review did not identify any unexpected results or related issues during the manufacturing process.Customer release test (crt) results for lot 34457fn00 were within specifications.Clinical sensitivity was performed using a retained kit of reagent lot 34457fn00.The sensitivity panel met specifications and no false nonreactive result was obtained.Furthermore, a commercially available seroconversion panel (zeptometrix hbv seroconversion panel hbv11003) was tested.The seroconversion panel results were compared to historical data of alinity s hbsag and reagent lot 34457fn00 detected the same bleeds as reactive for the seroconversion panel.Labeling was reviewed and sufficiently addresses the customer's issue.The test results associated with sid (b)(6) were reviewed by the abbott transfusion medicine global medical director.In the absence of detailed donor history, the pattern of specific markers in this sample could be interpreted as either resolving acute hbv infection with hbv dna and hbsag at barely detectable to undetectable levels, or as a chronic infection with occasional detectability of hbv genetic material replication.In these cases, the hbsag concentration may be low enough to be barely detectable or undetectable from an analytical standpoint, causing discrepant results between different serologic platforms and inconsistency on repeat testing with the same platform.Further donor counseling and medical follow-up (per hkrc institutional protocol, hkrc medical director evaluation, and clinical parameters) may be warranted in light of the possibility of acute or chronic hbv infection.Based on our investigation, no systemic issue or deficiency with the alinity s hbsag reagent, lot number 34457fn00 was identified.This report is being filed on an international product, alinity s hbsag, list number 06p02-55, that has a similar product distributed in the us, list number 06p02-60.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Type of Device: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND 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: 15140625
• MDR Text Key: 297226598
• Report Number: 3008344661-2022-00085
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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
• Report Date: 08/01/2022

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: 11/04/2022
• Device Catalogue Number: 06P02-55
• Device Lot Number: 34457FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1171