Catalog Number 05589061190 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2022 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable dbili direct bilirubin gen.2 results for 1 patient sample on a cobas integra 400 plus module compared to a beckman analyzer.On (b)(6) 2022, the initial dbili result was 5.65 mg/dl.The result was reported outside of the laboratory.The doctor questioned the result as it did not match the patient's clinical picture and the sample was repeated the next day.On (b)(6) 2022, the sample was repeated and the result was 5.37 mg/dl.The sample was sent to another lab and tested on a beckman analyzer on the same day.The beckman analyzer result was 3.70 mg/dl.The beckman analyzer result was deemed correct.The integra 400 plus analyzer serial number is (b)(4).
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Manufacturer Narrative
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The customer did not perform qc on the day of the event.It was previously performed on (b)(6) 2022 and was acceptable.Calibration was last performed on (b)(6) 2022.The alarm trace showed several no fluid detected and clot detected alarms.The patient sample was found to be icteric.The investigation is ongoing.
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Manufacturer Narrative
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The investigation determined there were no interfering substances in the patient sample.The investigation did not identify a product problem.
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Search Alerts/Recalls
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