ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 02G22-25 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2023 |
Event Type
malfunction
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Event Description
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The customer observed a false nonreactive architect hbsag result for one patient that was previously reactive.The following data was provided: on (b)(6) 2023, sid (b)(6) initial result = 0.2252 (nonreactive), repeat = 290.6695 (reactive).On (b)(6) 2023, sid (b)(6) initial result = 0.2944 (nonreactive), repeat = 4228.0861 (reactive).The samples were repeated on (b)(6) 2023 after the initial results were questioned by the patient.No impact to patient management was reported.
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Manufacturer Narrative
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Patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The complaint investigation for false nonreactive architect 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 in-house sensitivity testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any nonconformances, potential nonconformances, or deviations with lot 43075fn00 and the complaint issue.In-house sensitivity testing using a retained reagent kit of lot 43075fn00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect hbsag qualitative ii reagent for lot 43075fn00 was identified.
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