Catalog Number 03183696122 |
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 06/09/2022 |
Event Type
malfunction
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Event Description
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The initial reporter received questionable iron gen.2 results on a cobas 6000 c501 (ul) v.The reporter used previous patient samples to do a lot-to-lot correlation.For patient #1, the previous iron result was 35 ug/dl.The repeat result on the new lot was 57 ug/dl.For patient #2, the previous iron result was 43 ug/dl.The repeat result on the new lot was 21 ug/dl.The previous results were reported outside of the laboratory.It is not known which result is deemed correct.The old lot was 59326101 and the expiration date is 30-nov-2022.The new lot was 60819101 and the expiration date is 31-jan-2023.The instrument serial number is (b)(4).
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Manufacturer Narrative
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The reporter received calibration errors and failed lot to lot comparisons.It was determined that air bubbles in the reagent pack were affecting results.Cal and qc passed after manually removing bubbles from the reagent pack.The investigation is ongoing.
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Manufacturer Narrative
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It was determined that the discrepant results were due to customer handling of reagents which caused the formation of foam in the reagents.Product labeling states: "foam on top or bubbles in reagents can cause pipetting volume shortage and lead to incorrect results.Avoid the formation of foam in all reagent types.Do not shake reagents." and "do not shake the cobas c pack to avoid foaming." there were multiple calibration failures and controls were outside of the high range on the day of the event.Successful calibration and controls were then measured later that day.Abnormal probe aspiration errors were observed on the alarm trace.These are indicators of possible poor sample quality the issue was resolved by removing the bubbles and repeating calibration, qc, and patient correlations successfully.
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Search Alerts/Recalls
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