Catalog Number 07C18-39 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/03/2020 |
Event Type
malfunction
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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.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number (b)(4) that has a similar product distributed in the us, list number (b)(4).
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Event Description
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The customer reported a falsely elevated architect anti-hbs result on an (b)(6) patient.Results provided: (b)(6) 2020 = 34.4 miu/ml (anti-hbs concentration greater than or = 10 miu/ml is regarded as being protective against hepatitis b viral infection); additional testing provided: architect hbsag = 121.0 iu/ml.(b)(6) 2019 another facility anti-hbs = negative; (b)(6) 2019 architect anti-hbs = 18.2 miu/ml, hbc = 7.65 s/co.No impact to patient management was reported.
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Manufacturer Narrative
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Ticket searches and performance testing could not be performed as the likely cause lot number is unknown.There are no trends for the product related to patient results.No customer returns were available for evaluation.A review of overall customer field data was performed to assess the performance of the architect anti-hbs assay and is within the established baselines confirming no systemic issues in the field.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.
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Search Alerts/Recalls
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