ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM
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Catalog Number 07248563190 |
Device Problems
False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problems
Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 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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Event Description
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A customer from (b)(6) alleged the generation of false mutation detected results for ex20ins mutation with the cobas® egfr mutation test v2 compared to oncomine dx.No harm or injury was reported.Initially, the sample was tested on the cobas® assay, which detected ex20ins mutation.When retested on ngs (oncomine dx), no mutation detected was generated (date unknown).Although requested, data runs, dates of testing, kit lot information, sample ids, and other information that would assist with the investigation were not provided.It is unknown if the customer used roche¿s dna sample preparation kit.
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Search Alerts/Recalls
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