MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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 Positive Result (1227)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

The customer observed false reactive results for alinity i hbsag qualitative ii for one female patient.The patient was reactive on two tests 14 days apart.The patient was nonreactive with roche and siemens methods.The following data was provided: two screening alinity i hbsag results 14 days apart = 13 and 11 s/co.Samples were repeated and confirmed by neutralization per package insert.No specific data available for those tests.Per alinity i hbsag qualitative ii package insert < 1.00 nonreactive no retest required.= 1.00 reactive retest in duplicate no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Section d9 date returned to mfg should be blank corrected from 05/18/2023.

Manufacturer Narrative

Type of investigation included b08 testing of patient sample or reference material using manufacturer's device.D4 catalog # updated size code.Should be 08p10-32 was 08p10-22.

Event Description

The customer observed false reactive results for alinity i hbsag qualitative ii for one female patient.The patient was reactive on two tests 14 days apart.The patient was nonreactive with roche and siemens methods.The following data was provided: two screening alinity i hbsag results 14 days apart = 13 and 11 s/co samples were repeated and confirmed by neutralization per package insert.No specific data available for those tests.Per alinity i hbsag qualitative ii package insert < 1.00 nonreactive no retest required.= 1.00 reactive retest in duplicate no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive alinity i hbsag qualitative ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, return testing and inhouse testing of reagent lot 44577fn00.The ticket trending review of at least 12 months complaint data for the likely cause list number 8p10 did identify an increase in complaint activity for issue of false positive results.However, no commonalities for lot number and issue were identified.Device history record review did not identify any non-conformances or deviations with lot 44577fn00 and the complaint issue.Clinical specificity testing of alinity i hbsag qualitative ii reagent 08p10, lot 44577fn00, was performed using retained kits.Testing met all acceptance criteria indicating the products are performing as expected and there is no issue with the lot.Customer returns analysis was performed with patient specimens (ids (b)(6).& (b)(6).).The return specimens (ids (b)(6).& (b)(6).) generated repeat reactive results when tested with alinity i hbsag qualitative ii reagent, lot 44577fn00, but were not confirmed inhouse when tested with alinity i hbsag qualitative ii confirmatory reagent 08p11.The confirmed results obtained by the customer were not repeated inhouse.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent for lot 44577fn00 was identified.

Event Description

The customer observed false reactive results for alinity i hbsag qualitative ii for one female patient.The patient was reactive on two tests 14 days apart.The patient was nonreactive with roche and siemens methods.The following data was provided: two screening alinity i hbsag results 14 days apart = 13 and 11 s/co samples were repeated and confirmed by neutralization per package insert.No specific data available for those tests.Per alinity i hbsag qualitative ii package insert < 1.00 nonreactive no retest required.= 1.00 reactive retest in duplicate no impact to patient management was reported.

• 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 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16776976
• MDR Text Key: 313725326
• Report Number: 3008344661-2023-00081
• 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,Followup,Followup
• Report Date: 08/28/2023

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: 09/29/2023
• Device Catalogue Number: 08P10-32
• Device Lot Number: 44577FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 06/20/2023; 08/24/2023
• Supplement Dates FDA Received: 06/20/2023; 06/20/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Female