A us customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to replicate testing.Siemens is investigating.The instructions for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states the following: "note do not interpret levels of ca 27.29 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27.29 within the range observed in healthy individuals.Additionally, elevated levels of ca 27.29 can be observed in patients with nonmalignant diseases.Measurements of ca 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".
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The initial mdr, 1219913-2022-00008, was filed on 6 january 2022.14 april 2022 - additional information.A united states (us) customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to other replicates.For sample cf091811n, the same calibration, the same primary pack and the same ancillary pack were used to generate both the low and high results therefore they do not appear to be the cause of the bias in results.Atellica im br kit lot 259 expired 2022/01/14, so no internal studies were done with the lot, and the customer moved to atellica im br kit lot 261 in early december.A search of the complaint database found no other complaints about atellica im br kit lot 259.A review of internal data indicates atellica im br kit lot 259 is performing as intended.The cause(s) of the variability of patient sample recovery run to run seen by the customer when using atellica im br kit lot 259 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.This support task investigation is complete.In section h6, the investigation findings and investigation conclusion codes were updated to reflect the investigation results.
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