Catalog Number 03P36-25 |
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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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer stated that a falsely elevated architect afp result of 43.89 ng/ml was generated for a patient sample that retested at 1.88 ng/ml.The customer's normal rsnge is 0.89 - 8.78 ng/ml.The elevated result does not fit the clinical picture.No adverse impact to patient management was reported.
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Manufacturer Narrative
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Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Based on the available information, no product deficiency was identified.
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Search Alerts/Recalls
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