Catalog Number 04491785190 |
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 02/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer used an expired dilution reagent for the first repeat result of the sample.Product labeling states "diluent universal 2 stability: unopened at 2-8 °c up to the stated expiration date.Stability: on the analyzers at t 20-25 °c 12 weeks." a new patient sample from (b)(6) 2023 is available and was requested for investigation.The investigation is ongoing.
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Event Description
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The initial reporter received a questionable elecsys ferritin result for one patient sample tested on the cobas 6000 e601 module serial number (b)(4).The initial result was reported outside of the laboratory.The reporter would like to understand the difference in ferritin results between the roche module's electrochemiluminescence immunoassay (eclia) method and an unspecified module's chemiluminescent immunoassay (clia) method used in the partner laboratory.The initial result from the module was 2000 ng/ml with a data flag.The first repeat result from the module with the patient sample at 1/100 dilution factor was 166119 ng/ml with a data flag.The second repeat result from the other module with the patient sample at a dilution factor of 1/5 factor was 8.250 ng/ml.
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Manufacturer Narrative
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The patient sample was received for investigation.The results reported by the customer were comparable with the results obtained by the investigation.The clinical chemistry method for ferritin also detected a high ferritin value.No heterophilic antibodies seem to be present in this patient sample, as the results after the heterophilic blocking tube (hbt) treatment did not decrease.A general reagent issue can be excluded.The investigation is ongoing.
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Manufacturer Narrative
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The customer's last calibration performed on (b)(6) 2023 was acceptable.The customer's quality control results were within specifications.The provided patient sample was also tested by using a 1:50 dilution.Both methods, the elecsys as well as the clinical chemistry method for ferritin show values far above the measuring range and comparable to the results reported by the customer.The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.
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Search Alerts/Recalls
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