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 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information for section a1 patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8p10-32 has a similar product distributed in the us, list number 8p10-21/-31.

Event Description

The customer observed false reactive alinity i hbsag qualitative ii results for multiple samples.The following data was provided: (b)(6) 2023, sid (b)(6): initial result (module 3/ai02069) = 6001.67 s/co, repeats (module 3/ai02069) = 6004.28 s/co, 0.37 s/co, 0.39 s/co, 6052.68 s/co repeats (module 2/ai03832) = 0.28 s/co, neutralizing confirmatory initial result = unable to calculate result.Constituent assay (hbsagquac2) number result out of range (negative), repeat = 100%.(b)(6) 2023, sid (b)(6): initial result (module 2/ai03832) = 5931.84 s/co, repeat (module 2/ai03832) = 6071.31 s/co, repeats (module 3/ai02069) = 5827.09 s/co and 0.30 s/co, neutralizing confirmatory initial result = 99%, repeat = and unable to calculate result.Constituent assay (hbsagquac2) result out of range (negative).(b)(6) 2023, sid (b)(6): initial result (module 1) = 1.15 s/co, repeat (module 1/ai03830) = 1.05 s/co, repeats (module 3/ai02069) = 0.73 s/co, 0.58 s/co, 0.63 s/co, 0.66 s/co, 0.61 s/co, 0.63 s/co, 0.56 s/co, 0.80 s/co, repeat (module 2/ai03832) = 0.88 s/co, neutralizing confirmatory initial result = unable to calculate result.Constituent assay (hbsagquac2) number result out of range (negative), repeated 9 times and generated the same result.(b)(6) 2023, sid (b)(6): initial result (module 3) = 44.87 s/co, repeats (module 2/ai03832) = 0.49 s/co, 0.41 s/co, 40.64 s/co, neutralizing confirmatory initial result = 100%, repeat = unable to calculate result.Constituent assay (hbsagquac2) number (438) result out of range (negative).(b)(6) 2023, sid (b)(6): initial result (module 3/ai02069) = 15.41 s/co, repeats (module 3/ai02069) = 15.20 s/co, 0.31 s/co, 0.31 s/co, 0.26 s/co, neutralizing confirmatory initial result = 100% no impact to patient management was reported.

Event Description

The customer observed false reactive alinity i hbsag qualitative ii results for multiple samples.The following data was provided: 19jul2023 sid (b)(6) initial result (module 3/ai02069) = 6001.67 s/co, repeats (module 3/ai02069) = 6004.28 s/co, 0.37 s/co, 0.39 s/co, 6052.68 s/co repeats (module 2/ai03832) = 0.28 s/co, neutralizing confirmatory initial result = unable to calculate result.Constituent assay (hbsagquac2) number result out of range (negative), repeat = 100% 26jul2023 sid (b)(6) : initial result (module 2/ai03832) = 5931.84 s/co, repeat (module 2/ai03832) = 6071.31 s/co, repeats (module 3/ai02069) = 5827.09 s/co and 0.30 s/co, neutralizing confirmatory initial result = 99%, repeat = and unable to calculate result.Constituent assay (hbsagquac2) result out of range (negative).26jul2023 sid (b)(6) initial result (module 1) = 1.15 s/co, repeat (module 1/ai03830) = 1.05 s/co, repeats (module 3/ai02069) = 0.73 s/co, 0.58 s/co, 0.63 s/co, 0.66 s/co, 0.61 s/co, 0.63 s/co, 0.56 s/co, 0.80 s/co, repeat (module 2/ai03832) = 0.88 s/co, neutralizing confirmatory initial result = unable to calculate result.Constituent assay (hbsagquac2) number result out of range (negative), repeated 9 times and generated the same result.29jul2023 sid (b)(6) initial result (module 3) = 44.87 s/co, repeats (module 2/ai03832) = 0.49 s/co, 0.41 s/co, 40.64 s/co, neutralizing confirmatory initial result = 100%, repeat = unable to calculate result.Constituent assay (hbsagquac2) number (438) result out of range (negative) 18jul2023 sid (b)(6) initial result (module 3/ai02069) = 15.41 s/co, repeats (module 3/ai02069) = 15.20 s/co, 0.31 s/co, 0.31 s/co, 0.26 s/co, neutralizing confirmatory initial result = 100% 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, and field data review.Return testing was not completed as returns were not available.A search for similar complaints did not identify an increase in complaint activity for the issue.Trending review did not identify any related trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 49502fn00 and the complaint issue.The overall performance of alinity i hbsag qualitative ii was reviewed using field data from customers worldwide.The patient median result for lot 49502fn00 is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.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 49502fn00 was identified.

• 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: 17586585
• MDR Text Key: 321582189
• Report Number: 3008344661-2023-00158
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 08P10-32
• Device Lot Number: 49502FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBS AG QUAL CON, 08P11-22, 48280FN00; ALNTY I HBS AG QUAL CON, 08P11-22, 48280FN00; ALNTY I PROCESSING MODU, 03R65-01, AI02069; ALNTY I PROCESSING MODU, 03R65-01, AI02069; ALNTY I PROCESSING MODU, 03R65-01, AI03830; ALNTY I PROCESSING MODU, 03R65-01, AI03830; ALNTY I PROCESSING MODU, 03R65-01, AI03832; ALNTY I PROCESSING MODU, 03R65-01, AI03832