ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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Catalog Number 04P54-25 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2023 |
Event Type
Injury
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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.
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Event Description
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The customer observed a falsely elevated architect hbsag qualitative confirmatory result generated on the architect i2000sr processing module for a female patient who is a mother of a newborn.25sep2023 an obstetric gynecology (obgyn) physician questioned a confirmed positive result for a mother of a newborn.The initial reactive results of the mother was recentrifuged and repeat reactive in duplicate with a confirmed positive result that had similar s/co values and % neutralization (no specific data was provided).Based on the confirmed result, the infant was given hepatitis b immune globulin treatment.On (b)(6) 2023 the mother was redrawn and was negative for hbsag and the viral load testing performed was negative.No further impact to patient management was reported.
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Event Description
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The customer observed a falsely elevated architect hbsag qualitative confirmatory result generated on the architect i2000sr processing module for a female patient who is a mother of a newborn.25sep2023 an obstetric gynecology (obgyn) physician questioned a confirmed positive result for a mother of a newborn.The initial reactive results of the mother was recentrifuged and repeat reactive in duplicate with a confirmed positive result that had similar s/co values and % neutralization (no specific data was provided).Based on the confirmed result, the infant was given hepatitis b immune globulin treatment.On (b)(6) 2023 the mother was redrawn and was negative for hbsag and the viral load testing performed was negative.No further impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation for false reactive architect hbsag qualitative confirmatory 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 testing.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.A review of tracking and trending did not identify any related trends for the product for the issue.Device history record review on lot 54583fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house specificity testing was performed using an in-house retained kit of lot 54583fn00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency with the architect hbsag qualitative confirmatory assay for lot 54583fn00 was identified.All available patient information was included.Additional patient details are not available.
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