Catalog Number 07251670190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2023 |
Event Type
malfunction
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Event Description
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The initial reporter stated they received discrepant results for two samples collected from one patient and tested with elecsys anti-ccp on a cobas 6000 e 601 module (serial number (b)(4) and a cobas e 801 analytical unit (serial number (b)(4).The sample results were reported outside of the laboratory to the patient.When the first sample was tested on the e 801 analyzer, it resulted in an anti-ccp value of 41.1 u/ml on (b)(6) 2023.This sample was repeated on the e 601 analyzer on (b)(6) 2023, resulting in a value of < 7.00 u/ml with a data flag.The second sample had similar results.On (b)(6) 2023, the second sample resulted in an anti-ccp value of 38.0 u/ml when tested on the e 801 analyzer.This sample resulted in a value of < 7.00 u/ml when tested on the e 601 analyzer.Anti-ccp reagent lot 66022801 (expiration date = 30-sep-2023) was used on the e 801 analyzer.Anti-ccp reagent lot 637426 was used on the e 601 analyzer.This reagent expiration date was requested, but not provided.
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Manufacturer Narrative
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One patient sample was provided for investigation and the customer's results could be reproduced.Na.
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Manufacturer Narrative
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The patient is healthy and participates in a lot of sports.The patient had negative results for crp and rheumatoid factor.The last calibration performed on 14-dec-2022 was within expectations.Quality controls recovered within specified ranges.Further investigations of the patient sample determined that it contains a potential interfering factor against a component of one lot of anti-ccp reagent (lot 637426), resulting in a false low anti-ccp value.Further clarification of the observed discrepancy was not possible with available methods and the current state of the art.
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Search Alerts/Recalls
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