Catalog Number 07251670190 |
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 08/10/2023 |
Event Type
malfunction
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Event Description
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The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys anti-ccp (anti-ccp) on a cobas e 801 analytical unit compared to a competitor method.The initial result from the e801 analyzer was > 500 u/ml.The sample was repeated by a competitor method (immunocap 250) and the result was 0.2 moc (reference range <1.0).On (b)(6) 2023 the customer repeated the original patient sample for confirmation on the e801 analyzer and the result was > 500 u/ml.
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Manufacturer Narrative
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The sample was requested for investigation.
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Manufacturer Narrative
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The sample was investigated further where an interference against the streptavidin component of the assay was identified.This interference caused the high anti-ccp results.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.
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Manufacturer Narrative
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Section b3 was updated.The customer's e801 analyzer serial number was (b)(6).The initial report stated: "the sample was repeated by a competitor method (immunocap 250) and the result was 0.2 moc (reference range: 1.0)." this should say: "on (b)(6) 2023 a new sample was obtained and tested by a competitor method (immunocap 250) and the result was 0.2 moc (reference range: 1.0)." the initial report stated: "on (b)(6) 2023 the customer repeated the original patient sample for confirmation on the e801 analyzer and the result was: 500 u/ml." this should say: "on (b)(6) 2023 the customer repeated the original patient sample for confirmation from the 'long-term serotheque' and the result was: 500 u/ml." the patient sample was received for investigation and tested with elecsys anti-ccp reagent lot 714474 on a cobas e 801 analytical unit.The customer's anti-ccp result was reproduced on the e801 analyzer at the investigation site (500 u/ml with a data flag).The sample underwent rheumafactor interference testing.The rheumatoid factor in the sample was below 14 iu/ml, and therefore within the normal range (4.8 iu/ml).Based on this result, the sample was further tested for iga, igm, and igg to check for a high immunoglobulin, however, all immunoglobulin testing was within the normal range: iga2 = 1.22 g/l.Igg2 = 11.04 g/l.Igm2 = 1.89 g/l.The investigation is ongoing.
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Search Alerts/Recalls
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