Model Number CA 19-9 ELECSYS E2G |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation did not identify a product problem.The cause of the event could not be determined. per product labeling for the assay "the measured ca 19-9 value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the ca 19-9 assay method used.Ca 19-9 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the ca 19-9 assay procedure used while monitoring therapy, then the ca 19-9 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.".
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Event Description
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There was an allegation of questionable ca 19-9 elecsys results from cobas e 801 analytical unit serial number (b)(4).The exact date of the event was not known.(b)(6) 2021 was used as an approximation as this was the date the sample was taken from the patient.The initial results were 272 u/ml and 283 u/ml.The sample was sent to another hospital and tested with an unknown method.The result was about 20 u/ml.The sample was sent for preliminary investigation and the result from a cobas e801 was 297 u/ml, from a cobas e601 was 304.2 u/ml, and from the lumipulse was 738 u/ml.The questionable result was reported outside of the laboratory.
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Search Alerts/Recalls
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