Catalog Number 07K76-35 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2023 |
Event Type
malfunction
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Event Description
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The customer observed a falsely depressed architect prolactin result for a 48 year old female patient.The following data was provided (customer provided normal range: 5.18 to 26.0 ng/ml): (b)(6) 2023, sid (b)(6), initial result (lot 48500ud00) = 74.86 ng/ml.(b)(6) 2023, sid (b)(6), initial result (lot 51258ed00) = 15.68 ng/ml.The customer is questioning the new sample that was collected on (b)(6) 2023.The patient has a history of a pituitary tumor and previous prolactin results were in the range of 50 to 70 ng/ml.No impact to patient management was reported.
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Manufacturer Narrative
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Completed information for section a1 patient identifier: sid (b)(6).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 observed a falsely depressed architect prolactin result for a 48 year old female patient.The following data was provided (customer provided normal range: 5.18 to 26.0 ng/ml): 04sep2023 sid (b)(6) initial result (lot 48500ud00) = 74.86 ng/ml.25sep2023 sid (b)(6) initial result (lot 51258ed00) = 15.68 ng/ml.The customer is questioning the new sample that was collected on (b)(6) 2023.The patient has a history of a pituitary tumor and previous prolactin results were in the range of 50 to 70 ng/ml.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation for falsely depressed architect prolactin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing.Return testing was not completed as returns were not available.A review of customer data aligned with the customer¿s issue and no additional issues were identified.A search for similar complaints indicates that reagent lot 51258ud00 performs as expected.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 51258ud00 and the complaint issue.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit with complaint lot number 51258ud00.All specifications were met indicating that lot 51258ud00 is performing acceptably.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the architect prolactin reagent lot number 51258ud00 was identified.
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Search Alerts/Recalls
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