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 will be 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).(b)(4).
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A customer from (b)(6) alleged a false positive exon20ins result with a tissue sample when testing with the cobas® egfr mutation test v2.No run data was provided for evaluation.The cobas egfr mutation test v2 generated an exon20ins in combination with a l858r mutation.When retested with sanger sequencing, only the l858r mutation was detected (i.E., no exon20ins detected).No run data was provided for evaluation.No allegation of harm or serious injury was made.
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