Catalog Number 07C18-41 |
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 Type
malfunction
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Manufacturer Narrative
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All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, architect (b)(4), that has a similar product distributed in the us, (b)(4).
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Event Description
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The customer observed a (b)(6) anti-hbs result for one patient on the architect i2000sr analyzer.The following data was provided for a (b)(6) cancer patient: initial 53 miu/ml, repeated on another method as negative.There was no impact to patient management reported.
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Manufacturer Narrative
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Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No return patient sample was available.A significant value decrease was observed during antigen addition testing indicating possible interference in the specimen and it is possible that the anti-hbs result of 53miu/ml is a true positive result.Clinical specificity testing of negative panel replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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Search Alerts/Recalls
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