Catalog Number 09203079190 |
Device Problems
False Negative Result (1225); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the cobas e 801 module is (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter received a questionable elecsys anti-sars-cov-2 s (anti-sars-cov-2 s) result from a patient sample tested on a cobas e 801 module.The patient sample was rerun as part of troubleshooting.On (b)(6) 2023: the initial result was 0.202 (negative).On (b)(6) 2023: the repeat result was 2.18 (positive).The result was confirmed as positive with a third run.The unit of measurement was not provided.
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Manufacturer Narrative
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Medwatch field d4 lot no and expiration date was updated.The investigation reviewed the calibration data on (b)(6) 2023; the results were within specifications.There was no influence of the calibration on the event.The investigation reviewed the qc data; the results were within specifications for both positive and negative controls before the patient sample was run and before the module was released for patient measurement.The investigation reviewed the alarm trace from the date of the event; no issues were noted.The investigation reviewed the customer's handling of patient samples.The customer's centrifugation time and force were below the recommended settings by the tube manufacturer.The investigation excluded a general reagent problem because the qc before the event was within range.The investigation determined the event was consistent with a preanalytic issue at the customer site (the customer's centrifugation settings were below the recommended settings).
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Search Alerts/Recalls
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