MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07P89-22

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information: no specific patient information was provided.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 anti-hbs result on one patient.The results provided were: initial=(b)(6) (>or =(b)(6) consider being protective against (b)(6)) /no history of (b)(6)vaccination.There was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 field data of alinity i anti-hbs reagent lot 19104fn00.The evaluation of complaint data for the product and likely cause alinity i anti-hbs reagent lot 19104fn00 did not identified increased in complaint activity.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of reagent lot 19104fn00 was evaluated using worldwide data from abbottlink.The patient median result for this lot is comparable with other lots in the field and confirms no systemic issue.Per product labelling, if the anti-hbs 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, chronic, or recovered infection.The overall specificity for the alinity i anti-hbs assay (determined by considering result values of = 10.00 miu/ml as reactive) was estimated to be 99.76% at the lower 95% confidence level, therefore false reactive results may at times occur.False positive results may arise because of sample or reagent integrity issues at time of testing and details regarding sample and reagent handling are provided within the product package insert.The alinity ci-series operations manual, section 10, troubleshooting, provides probable causes and corrective actions for erratic results.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i anti-hbs assay lot number 19104fn00.

Manufacturer Narrative

Section g1 contact information was updated to reflect the current contact (b)(6).This submission send to correct section h6: medical device problem code updated to a090809 from a090804.

• Brand Name: ALINITY I ANTI-HBS 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, IL N39E9-32 ; EI N39E932 ; 2246682940
• MDR Report Key: 12626167
• MDR Text Key: 283596731
• Report Number: 3008344661-2021-00184
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Catalogue Number: 07P89-22
• Device Lot Number: 19104FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).