Catalog Number 07K70-25 |
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.Note: this report is being filed on an international product, architect total psa ln 7k70 that has a similar product distributed in the us, list number 6c06.
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Event Description
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The customer observed falsely elevated total psa results for one patient on the architect i2000sr analyzer.The following data was provided for a post-op patient being monitored for prostate cancer: initial 0.47 ng/ml, repeat 0.Confirmed as 0.003 ng/ml on another method.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 and instrument service.No adverse trend was identified for the customer's issue.A review of customer field data was performed which shows no atypical performance with reagent lot 03081fn00.A review using search of the corrective and preventive actions system and manufacturing documentation did not identify issues associated with the customer's observation.Return not available.Labeling was reviewed and found to be adequate.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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