Catalog Number 05031656190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The initial reporter received a questionable elecsys anti-ccp immunoassay result for one patient tested on a cobas 6000 e 601 module.The initial result was reported outside the laboratory to a clinician.The clinician was alerted of the questionable result due to the result not matching the patient's clinical picture and rheumatoid factor results.The patient's serum sample was tested for confirmation.The patient¿s anti-ccp result with a plasma sample was "weak positive." the patient¿s anti-ccp result with a serum sample was "negative" (<7 iu/ml).The patient's serum result was determined correct.The e 601 module serial number is (b)(4).
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Manufacturer Narrative
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The customer's calibration and qc were acceptable.The investigation discovered patterns of discrepant results between serum and plasma samples from the same blood draw of a given patient: negative results or results below the cutoff value on serum samples and positive results on plasma samples.Also, the concentrations obtained from plasma samples are dependent on the reagent lots used for testing.Further investigations were conducted and the investigation could not identify the root cause.
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Search Alerts/Recalls
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