Catalog Number 07248563190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is ongoing, a follow up report will be submitted to share the conclusions.Na.
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Event Description
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A customer from india alleged discrepant results for one patient when using cobas egfr mutation test v2.On (b)(6) 2022 a plasma sample was tested using cobas egfr mutation test v2 and generated an ex19del mutation detected result.On (b)(6) 2022, a tissue sample from the same patient was tested using cobas egfr mutation test v2 and ex19del mutation was not detected.No harm alleged to date.
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Manufacturer Narrative
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Data was provided and reviewed.A review of the growth curves showed no abnormalities.Furthermore, there was no sign of growth in the ex19del in the tissue sample.Controls were valid and internal controls generated robust results.The observed discrepancy is most likely due to the differences between the sample specimen types (tissue vs plasma).The plasma specimen represents the amount of mutations in the cell-free dna during the time of blood collection whereas tissue contains dna that was collected during biopsy.Although the tissue is considered a "golden standard", it is possible that the ffpet (tissue) slide used for testing did not contain any/very low amount of ex19del mutation whereas the cfdna contained more.In addition, there are differences in results calculations between plasma and tissue specimen types.
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Search Alerts/Recalls
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