Catalog Number 07K70-27 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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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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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 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 depressed prostate specific antigen (psa) results while using the architect total psa (prostate specific antigen) reagents.The following data was provided: initial 0.00 ng/ml, repeat 0.00 ng/ml, previous results for the patient since 2015 were approximately 11.00 ng/ml.No impact to patient management was reported.
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Manufacturer Narrative
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Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, and labeling review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.
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Search Alerts/Recalls
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