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 02/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is on-going.J05038 = expiration date: 2023-12-31.J10355 = expiration date: 2024-03-31.J18917 = expiration date: 2024-06-30.E1 facility name truncated due to character limit:(b)(6) hospital.
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Event Description
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A customer from the united kingdom alleged discrepant results with the cobas® egfr mutation test v2.The customer reported that 5 patient samples showed mutation detected ((b)(4)), and no mutation detected during initial and repeat testing.
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Manufacturer Narrative
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A review of the data showed that out of 5 alleged samples 4 were at the limit of detection (lod) of the assay which explains the wavering results during repeat testing or sample stability issues.It was noted that some of the samples were tested outside of the method sheet instructions; "extracted dna is stable for up to 14 days at 2°c to 8°c." note, that a 6th sample was also alleged to have generated discrepant results that was found to be near the lod of the assay.The 5th sample was found to be related to a dirty lens in the detection unit of the cobas z 480 analyzer.The field service engineer visited the site and observed that the lens was dirty.The issue was resolved after the cleaning of the lens.The alleged result was not reported to the patient/treating physician.There is no allegation of harm.The issue has not reoccurred since.B6 and b5 were updated to include the additional 6th sample.
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Event Description
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The customer reported that 6 patient samples showed mutation detected (g719x or l858r or ex19del), and no mutation detected during initial and repeat testing.
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Search Alerts/Recalls
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