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 11/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is ongoing.
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Event Description
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A customer from hong kong alleged discrepant results with 3 patient samples using the cobas egfr mutation test, v2.Patient 1 initially generated no mutation detected result on (b)(6) 2022.The sample was sent for ngs in 2022 which generated l858r mutation detected result.A new specimen was collected in (b)(6) 2023 and tested on (b)(6) 2023 using the cobas egfr v2 test which generated l858r mutation detected result.Patient 2 initially generated no mutaton detected on (b)(6) 2023.The sample was sent for ngs which generated e709a;g179a mutation detected result.On (b)(6) 2023, the sample was retested on the cobas egfr v2 test and generated g179x mutation detected result.Patient 3 initially generated no mutation detected result on (b)(6) 2023.The sample was repeated on the cobas egfr v2 test which generated l858r mutation detected result.
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Manufacturer Narrative
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No product problem identified.The root cause contributing to the discrepant results observed by the customer is sample/site specific such as sample at the limit of detection (lod) and/or suboptimal workflow.Note, for the patient 1 sample, the off-label sample type (pericardial fluid) was likely a contributing factor.Per the method sheet, "the cobas egfr test has been validated for use with nsclc ffpet tumor samples and plasma separated from blood collected in the roche cfdna tube or k2 edta tube.".
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Search Alerts/Recalls
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