Catalog Number 07K70-30 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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This report is being filed on an international product list 7k70, that has a similar us product distributed in the us, list 6c06.The complete id is (b)(6).An evaluation is in process.A follow up report will be submitted when the evaluation is completed.
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Event Description
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The account generated false elevated architect total psa of 7.6 ng/ml on id (b)(6) that repeated 1.2, 1.2 ng/ml.No impact to patient management was reported.No specific patient information is available.
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Manufacturer Narrative
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The ticket searches determined normal complaint activity for the complaint lot.Complaint trending report review determined that there is no adverse trend for the product for the complaint issue.Instrument data analytics was reviewed which determined that the patient median result for the complaint lot is comparable with other lots in the field and confirms no systemic issue for the lot.A review of the product quality history for the lot number using search of the corrective and preventive actions system did not identify issues associated with the customer observation.No customer returns were available for evaluation.Labeling was reviewed which adequately addresses the current issue.No product deficiency was identified.
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Search Alerts/Recalls
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