Catalog Number 03P36-25 |
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.
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Event Description
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The customer observed discrepant alpha 1 fetoprotein (afp) results on the architect analyzer.The following data provided: initial 14, repeats 10, 20 for a patient between the ages of 1 and 3 years old.There was no impact to patient management reported.
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Manufacturer Narrative
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On march 19, 2019 additional patient details were provided.The child was diagnosed clinically with isolated mammoplasia.This was noted on clinical examination when the child presented with urinary tract infection at the age of 4 months.Sex hormones, hcg, tfts and general biochemistry were all normal (the child was 2 years old when seen last in opd).The expected result was expected to be normal in view of the above.An evaluation is still in process, a follow up report will be provided when the evaluation is completed.
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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 field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.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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