Model Number TRIGL |
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 03/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The calibration data trace showed multiple failed calibrations flagged with a standard error from (b)(6) 2023.When the error occurs, the prior calibration remains in effect.The qc data recovery was acceptable on the day of the event.A reagent issue could be ruled out because calibration and controls were acceptable.The alarm trace showed multiple abnormal probe-sucking errors.The customer changed the cuvettes and ran qc successfully.Precision studies were performed for multiple parameters and precision was acceptable for all except triglycerides.The field service engineer cleaned the probes.Special washes were checked and all were found to be installed.Precision studies and controls run after the service actions were ok.The investigation is ongoing.
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Event Description
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There was an allegation of questionable trigl triglycerides results for 2 patient samples on a cobas 6000 c501 module.For patient 1, the initial trigl result was 508.9 mg/dl.The repeat result was 292.9 mg/dl.For patient 2, the initial trigl result was 581.2 mg/dl.The repeat result was 157.0 mg/dl.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(4).
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Manufacturer Narrative
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The investigation did not identify a product problem.The investigation found that the root cause of the event was consistent with pre-analytical handling issues.
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Search Alerts/Recalls
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