ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Model Number 08P1021 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2023 |
Event Type
malfunction
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Event Description
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The customer observed false reactive alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory results for a pregnant female patient.The sample was pulled and repeated 4 days later with a nonreactive result.A second sample was drawn which generated a nonreactive result.The following data was provided: customer stated they had a sample that was drawn on (b)(6) 2023 that ran on (b)(6) 2023 and gave the following results according to customer: sid (b)(6) hbsag=1.04 hbsag confirmatory = reactive.Repeat of sample on (b)(6) 2023 sample was respun and reran in duplicate according to customer: hbsag=1.19, hbsag=1.27, hbsag confirmatory = 1.11 confirmed positive.Sample was rerun on (b)(6) 2023, result = sid (b)(6) hbsag=0.33 nonreactive.New sample drawn (b)(6) 2023 sid= (b)(6) hbsag = nonreactive hbsag confirmatory = negative.Per alinity i hbsag qualitative ii package insert < 1.00 nonreactive no retest required.= 1.00 reactive retest in duplicate no impact to patient management was reported.
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for patient identifier: sid (b)(6) and sid (b)(6).
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Manufacturer Narrative
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The complaint investigation included review of data and information provided by the customer, search for similar complaints, ticket and trending review, labeling review, device history review, and inhouse testing of retained reagent lot 44671fn00.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of false reactive results.The ticket and trending review for the complaint list number did not identify any trends.Device history review in did not identify any nonconformances or deviations associated with complaint lots and the customer¿s issue.Performance testing was performed using an in-house retained kit of complaint lots.Acceptance criteria was met indicating the lots are performing as expected.A review of the labeling adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent, lot 44671fn00 was identified.
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Search Alerts/Recalls
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