ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 08P08-32 |
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 02/28/2024 |
Event Type
malfunction
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Event Description
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The customer reported false reactive alinity i hbsag and provided the following data for sample id (b)(6) : initial result was 0.07 iu/ml and repeat result was 0.12 iu/ml (reference: = 0.05 iu/ml is reactive) the hbsag neutralization testing was confirmed positive and generated the following results: pretreatment 1 result was 0.50 s/co with a rlu of 397 and pretreatment 2 result was 1.35 s/co with a rlu of 1063 and the neutralization rate is (b)(4).Hbsag result tested on another analyzer (sn: (b)(6) and generated a negative result of 0.00iu/m and confirmatory testing generated a negative result with 1:500 dilution on the original analyzer (sn: (b)(6).Patient information: 61-year-old female with a negative hbsag testing history.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
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Manufacturer Narrative
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This report is being filed on an international product, list number 8p08-32 and there is a similar product distributed in the us, list number 4p53.A1 patient identifier: complete sample id is (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 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and field data 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 without indication for any additional issue.Device history review did not identify any non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review has not identified any trends.The overall performance of alinity i hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 53544fn00 indicated patient median results for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity i hbsag reagent lot 53544fn00.
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Event Description
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The customer reported false reactive alinity i hbsag and provided the following data for sample id (b)(6): initial result was 0.07 iu/ml and repeat result was 0.12 iu/ml (reference: = 0.05 iu/ml is reactive) the hbsag neutralization testing was confirmed positive and generated the following results: pretreatment 1 result was 0.50 s/co with a rlu of 397 and pretreatment 2 result was 1.35 s/co with a rlu of 1063 and the neutralization rate is (b)(4).Hbsag result tested on another analyzer (sn: ai23204) and generated a negative result of 0.00iu/m and confirmatory testing generated a negative result with 1:500 dilution on the original analyzer (sn: (b)(6)).Patient information: 61-year-old female with a negative hbsag testing history.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
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Search Alerts/Recalls
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