A customer from spain alleged discrepant results with 2 patient samples using the cobas® egfr mutation test v2.The alleged samples initially tested with the cobas® egfr mutation test v2 generated a "mutation detected" result for exon20ins.Both the samples were retested using next generation sequencing (ngs) and were negative for the exon20ins.Note, sample 2 was also positive for exon19del with the cobas® egfr mutation test v2 and ngs, therefore, there was no discrepancy for exon19del.The results were not reported.No harm was alleged.
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Roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees have been notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).H3 other text: na.
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