MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 02G22-25

Device Problem False Positive Result (1227)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results on one patient from two different specimens.The results provided were: on (b)(6) 2022.Sid (b)(6).First specimen initial=180.21 s/co (> or =1.00 s/co=reactive) /repeated=146.35 s/co /repeated by elfa method=reactive /hbsag confirmation=reactive (no actual results provided).Second specimen initial=0.26 s/co (< 1.00 s/co=nonreactive) /repeated=0.25 s/co.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for patient information 1.Patient identifier= sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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, field data for architect hbsag qualitative ii reagent, lot 39057fn00.Trending review determined no adverse trend for the issue for the product.The ticket search determined that there is as expected complaint activity for the likely cause lot.Return testing was not completed as returns were not available.Historical performance of the architect hbsag qualitative ii assay was evaluated using worldwide data from abbottlink.The number of standard deviations to the cut-off and the median of the negative populations for the lots are within the established limits and within the historical range of all other reagents lot numbers.Device history record review did not identify any non-conformances or deviations with the complaint lots and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for architect hbsag qualitative ii reagent, lot 39057fn00.

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results on one patient from two different specimens.The results provided were: on 09dec2022 sid (b)(6) first specimen initial=180.21 s/co (> or =1.00 s/co=reactive)./repeated=146.35 s/co /repeated by elfa method=reactive /hbsag confirmation performed at another reference laboratory prodia on (b)(6)=reactive (no actual results provided).Second specimen initial=0.26 s/co (< 1.00 s/co=nonreactive) /redrawn and repeated=0.25 s/co there was no reported impact to patient management.

• Brand Name: ARCHITECT 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: 16094478
• MDR Text Key: 307224194
• Report Number: 3008344661-2023-00001
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 02G22-25
• Device Lot Number: 39057FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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: ARC HBSAG QUAL II 50T, 02G23-25, UNKNOWN; ARC HBSAG QUAL II 50T, 02G23-25, UNKNOWN; ARC I1000SR INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).