Catalog Number 12017547122 |
Device Problems
Incorrect Measurement (1383); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2023 |
Event Type
malfunction
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Event Description
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The initial reporter complained of high results for 2 samples from 1 patient tested for elecsys insulin (insulin) on a cobas e 411 immunoassay analyzer.On (b)(6) 2023 the patient had an insulin result of 962.8 uu/ml with a data flag from the e411 analyzer.The repeat result was 960.8 uu/ml with a data flag.On (b)(6) 2023 a new sample was obtained and the result from the e411 analyzer was 966.0 uu/ml with a data flag.This sample was sent to another laboratory where the result from the maglumi method was 99.61 uu/ml and the result from the atellica method was 31.03 uu/ml.
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Manufacturer Narrative
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The e411 analyzer serial number is (b)(6).Qc was acceptable.On (b)(6) 2023 the customer treated the sample from (b)(6) 2023 with polyethylene glycol to test for interference and the result was 40.62 uu/ml.The investigation is ongoing.
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Manufacturer Narrative
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The insulin result from the atellica method of 31.03 uu/ml was believed to be correct as this coincides with the patient's clinical history.The calibration data provided from 06-aug-2023 was acceptable.Qc data provided between 05-jun-2023 and 05-aug-2023 was acceptable.The investigation determined the event was consistent with the presence of anti-insulin antibodies in the patient sample which are recognized by the elecsys insulin assay.This is confirmed by the result received by the customer after treating the sample with polyethylene glycol.A general reagent issue can be excluded as the provided quality control data is within expectations.Product labeling states: "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies which can affect the test results." the investigation did not identify a product problem.
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Search Alerts/Recalls
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