The customer contacted the siemens customer care center (ccc) to report discordant advia centaur xp br (ca 27.29) non-reproducible patient results.A siemens customer service engineer (cse) was dispatched to the customer site for system inspection.The cse performed a total service call and full system decontamination.The customer's quality control (qc) were within range prior to running the patient samples on (b)(6) 2020, however when qc was run the next day, it was 3sd out of range.The customer replaced the reagent pack, calibrated and reran qc, resulting within package insert ranges.The patient samples were repeated and resulted as expected.Based on the service activity, the customer replacing the reagent readypack, calibration and obtaining acceptable qc results, the potential cause is unknown.The customer does not require any further action on this issue as the reagent pack was replaced and expected results were obtained.A product non-conformance was not identified, and the system is operational.The instructions for use in the results interpretation section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specifications.No further evaluation of the device is required.
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Falsely elevated advia centaur xp br (ca 27.29) results were obtained on two patient samples and considered discordant compared to lower results when tested with new samples.The original samples had been previously tested at an alternate site (client), resulting lower.The discordant, br results were not reported to the provider(s).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant, falsely elevated advia centaur xp br (ca 27.29) results.
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