Catalog Number 07027273190 |
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 11/01/2022 |
Event Type
malfunction
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Event Description
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The initial reporter stated they received questionable results for one patient sample tested with the elecsys ferritin assay on a cobas e 801 analytical unit, serial number (b)(4).The results measured on the e 801 analyzer did not agree with other parameters for the patient and did not compare to the result obtained with a competitor method.On (b)(6) 2022 a sample was measured on the cobas e 801 analyzer, resulting in a ferritin value of <0.500 g/l, accompanied by a data flag.The sample was repeated seven times, every time resulting in a value of <0.500 g/l, accompanied by a data flag.On (b)(6) 2022 a sample was measured on the cobas e 801 analyzer, resulting in a ferritin value of <0.500 g/l, accompanied by a data flag.It was asked but it is unknown if the samples from (b)(6) 2022 derive from the same or different blood drawings of the patient.A sample was repeated on a competitor analyzer, resulting in a ferritin value of 11 g/l.It was asked but it is unknown which sample was remeasured on the competitor analyzer.It was asked but it is unknown whether a questionable result was reported outside of the laboratory.
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Manufacturer Narrative
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Na.
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Manufacturer Narrative
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It was confirmed that the samples from 01-nov-2022 and 15-nov-2022 derive from different blood drawings of the patient.Medwatch fields a3 and b7 have been updated.
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Manufacturer Narrative
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A sample of the patient was provided for investigation.The elecsys ferritin result of the customer could be reproduced.No interfering factor against the streptavidin component of the assay could be determined in the sample.The investigation is ongoing.
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Manufacturer Narrative
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Further investigation of the sample with a heterophilic blocking tube (hbt) did not show a change in results after treatment.There is no indication of the presence of heterophilic antibodies in the patient sample.The investigation is ongoing.
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Manufacturer Narrative
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Calibration and quality controls were acceptable.There is no indication of a general reagent issue.The sample was tested for additional interferences (biotin, ruthenium, bead treatment), but no interference factor could be identified.The investigation could not identify a product problem.The cause of the event could not be determined.Per product labeling: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".
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Search Alerts/Recalls
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