MAUDE Adverse Event Report: ABBOTT IRELAND 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 07/27/2022

Event Type  malfunction  

Event Description

The customer observed false reactive alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory results for a 69-year-old female dialysis patient with chronic kidney disease.A second sample was requested, and the result was still reactive.The patient went to another laboratory which generated a nonreactive result.A third sample was drawn from the patient and the result was nonreactive.The following data was provided: (b)(6) 2022 sid (b)(6) result (ai02993) = 3.38 s/co (reactive) sample was recentrifuged and repeated on ai02759 = 3.67 s/co (reactive) neutralization confirmatory results: c2= 3.00 s/co, %neutralization = 99% (confirmed positive) 2nd sample result (ai02759) = 3.00 s/co (reactive), did not repeat or perform confirmatory 3rd sample drawn (b)(6) 2022 result (ai02759) = 0.28 s/co (nonreactive) hbsag result at another laboratory (electrochemiluminescence method) = nonreactive no impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 8p10-32 that has a similar product distributed in the us, list number 8p10-21/-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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, device history record review, field data review and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 34461fn00 and complaint issue.The historical performance of the alinity i hbsag qualitative ii reagent was reviewed using field data from customers worldwide.The median patient result for lot 34461fn00 is within the established baseline, indicating the reagent lot is comparable with other lots in the field, confirming no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent for lot 34461fn00 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; 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: 15426953
• MDR Text Key: 302166180
• Report Number: 3008344661-2022-00110
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Catalogue Number: 08P10-32
• Device Lot Number: 34461FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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 Age: 69 YR
• Patient Sex: Female