Catalog Number 07248563190 |
Device Problem
False Positive Result (1227)
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Patient Problems
Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Event Description
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A customer alleged discrepant ex20ins results for one patient when using cobas® egfr mutation kit compared to the retest result.The initial test generated a positive result for ex20ins.Upon repeat testing, the sample did not detect ex20ins.The result was not reported out of the lab.No harm or injury was alleged.Additional information such as sample type, raw data and process was requested but not provided.
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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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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 alleged discrepant ex20ins results for one patient when using cobas® egfr mutation kit compared to the retest result.The initial test generated a positive result for ex20ins.Upon repeat testing, the sample did not detect ex20ins.The result was not reported out of the lab.No harm or injury was alleged.Additional information such as sample type, raw data and process was requested but not provided.
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Manufacturer Narrative
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Customer provided data and information about the alleged sample.B6 - relevant test/laboratory data was updated to include this information.The conclusion of the case remained unchanged.(b)(4).
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Search Alerts/Recalls
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