ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
|
Back to Search Results |
|
Catalog Number 08P11-22 |
Device Problem
False Positive Result (1227)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/27/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is being filed on an international product, list number 8p11-22 that has a similar product distributed in the us, list number 8p11-21.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
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: on (b)(4) 2022 sid (b)(4) 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 on (b)(4) 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
|
The complaint investigation false reactive alinity i hbsag quantitative ii confirmatory result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.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 number 33519fn00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met which indicates the lot is performing acceptably.Per product labeling, if the alinity i hbsag qualitative ii confirmatory 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 and chronic infection.Based on this investigation, no systemic issue or deficiency with the alinity i hbsag quantitative ii confirmatory reagent, lot number 33519fn00 was identified.
|
|
Search Alerts/Recalls
|
|
|