The investigation determined that there was reagent contamination, which occurred during the filling process of the elecsys ca 19-9 reagent cassettes lot number 416245 for the cobas e 801 module only.The issue is related to contamination of the reagent with magnetic particles.A replacement lot is not currently available.Roche has provided two workaround options to customers.The first workaround is customers may discontinue running the elecsys ca 19-9 assay on the e801 and instead run the ca 19-9 assay on the cobas e 411 analyzer, cobas e 601 and 602 modules, or the modular analytics e 170 module.The second workaround is customers can continue to run the ca 19-9 assay on the e801 and repeat all results =37 u/ml within 2 hours.Customers are also instructed to use only the first 200 determinations of the 300 test cobas e pack.Instructions for implementing these workarounds were communicated to customers by customer notification.This event occurred in (b)(6).
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The initial reporter received questionable elecsys ca 19-9 immunoassay results for six patient samples from cobas 8000 e 801 module serial number (b)(4).Patient 1 results: 34.8 u/ml, 68.3 u/ml, and 34.7 u/ml.Patient 2 results: 58.4 u/ml, 108 u/ml, 59.1 u/ml.Patient 3 results: 143 u/ml and 11.3 u/ml.Patient 4 results: 82.9 u/ml and 6.67 u/ml.Patient 5 results: 66.3 u/ml, 94.06 u/ml, and 67.2 u/ml.Patient 6 results: 73.1 u/ml, 7.18 u/ml, and 7.49 u/ml.No questionable result was reported outside of the laboratory.
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