Catalog Number 03P36-78 |
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 Date 07/30/2019 |
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.All available patient information was included.Additional patient details are not available.
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Event Description
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The customer reported a falsely elevated architect afp result on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 33.06 ng/ml / 3.12 ng/ml.No impact to patient management was reported.
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Manufacturer Narrative
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A review of tickets was performed for the likely cause architect afp reagent lot number 96121fn00.The ticket search determined that there is normal complaint activity for this lot number.Testing was performed in-house using a retained kit of lot# 96121fn00 and all specifications were met, indicating the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customers observation.Historical performance in the field of reagent lot 96121fn00 using world wide data through abbottlink was evaluated.The patient median result for this lot was analyzed and found to be within established baselines and confirms no systemic issues for this lot.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect afp lot# 96121fn00 assay.Correction:catalog # edited from 03p36-35 to 03p36-78.
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Search Alerts/Recalls
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