Siemens filed the initial mdr 1219913-2023-00278 on november 03, 2023.An outside united states (ous) customer contacted a siemens customer care center to report falsely depressed enzymatic creatinine_3 (ecre3) results were obtained on samples from two patients on an advia chemistry xpt system and considered discordant when compared to another replicate from the sample.November 08, 2023 additional information: the initial issue was reported as enzymatic creatinine 3 (ecre3 lot # 020) discordant results for patient samples using an advia chem xpt system (serial no: (b)(6).Siemens reviewed the available information in the complaint and the instrument data provided.The customer states that the issue is fixed by removing the bubbles in the reagent before loading.Based on the available information, the probable cause of the enzymatic creatinine 3 (ecre3 lot # 020) discordant results for patient samples is due to the bubble formation on the reagent which causes discordant results of ecre3, and issue is resolved by removing bubbles before loading.No further evaluation of the device is required.In section h6, the investigation finding and investigation conclusion codes were updated.
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