Catalog Number 07028148190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter received questionable elecsys vitamin d total ii results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys vitamin d results were reported outside the laboratory.The patient's physician did not believe the initial result.The customer performed repeat testing with the same sample on a diasorin analyzer and an antellica analyzer.The customer also sent the patient's sample to another laboratory to be tested on an unknown analyzer with liquid chromatography with tandem mass spectrometry (lc-ms/ms) methodology.On (b)(6) 2021, the patient's elecsys vitamin d result was 84.1 ng/ml.On (b)(6) 2021, the patient's vitamin d result on a diasorin analyzer was 40 ng/ml.The patient's vitamin d result on an atellica analyzer was 54 ng/ml.The date of measurement was requested but not provided.On (b)(6) 2021, the patient's vitamin d result with lc-ms/ms methodology was 82 ng/ml.The patient's physician believed the vitamin d results from the diasorin analyzer and atellica analyzer were correct.
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Manufacturer Narrative
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The customer's qc results were acceptable.The customer's system alarm trace and sample pre-analytical details were requested but not provided.The investigation confirmed the exact specificity of the lc-ms/ms method used for testing was not provided but the lc-ms/ms result was comparable to the elecsys result obtained.Based on the available data, the investigation determined the observed discrepancy between the elecsys vitamin d total ii assay and the diasorin and antellica methods was the presence of a significant amount of a vitamin d derivate (c3-epi) in the sample.Per product labeling, the elecsys vitamin d assay does not have cross-reactivity to the vitamin d derivate (c3-epi) up to a concentration of "50 ng/ml." the investigation did not identify a product problem.
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Search Alerts/Recalls
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