Catalog Number 08828644190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The investigation is ongoing.
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Event Description
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The initial reporter received questionable procalcitonin assay results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).The customer reported the procalcitonin result to a physician who asked for a re-measurement of the sample.The customer provided the sample for an investigation and the patient's sample was tested on a cobas 6000 e 601 module.The sample was outsourced and was tested on a lumipulse analyzer.On (b)(6) 2021, the patient's procalcitonin result on the customer's e 601 module was ">100" ng/ml.On (b)(6) 2021, the patient's undiluted procalcitonin result on the investigation's e 601 module was ">100" ng/ml.The investigation performed a 1:4 dilution with the patient's sample and the diluted procalcitonin result was 108.5 ng/ml.On (b)(6) 2021, the patient's procalcitonin result on the outsourced lumipulse analyzer was 71.4 ng/ml.
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Manufacturer Narrative
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The customer's calibration, qc, system alarm trace, and sample pre-analytical details were requested but not provided.The calibration and qc results on the investigation's cobas 6000 e 601 module were ok.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.Updated medwatch field d4 expiration date.
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Search Alerts/Recalls
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