The customer received questionable creatine kinase results for one patient sample from two cobas c501 analyzers.The initial result from cobas c501 serial number (b)(4) was 692.6 u/l with a data flag.The repeat testing gave no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the result was 296.4 u/l which was reported outside the laboratory.Later in the day, a repeat sample was received for the patient and the customer decided to repeat the original sample.The sample was repeated on cobas c501 serial number (b)(4) and the results were 341 u/l with a data flag and no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the results were 485.3 u/l with a data flag and no numeric result but a data flag.With a 1:20 dilution, the results in sample cups were 35748 u/l and 29164 u/l.The results with the dilution were believed to be correct and a corrected report was issued.The patient was not adversely affected.
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A specific root cause could not be identified.Based on the provided calibration, qc, and precision data, the instruments were working according to specifications.As only one sample was affected, the issue seems to be a preanalytic sample issue.
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