The siemens customer service engineer (cse) performed the following: the acid and base line of the equipment was decontaminated.The volume dispensing of acid base was reviewed.Average lumocheck is <400.General autocheck in optimal conditions cleaned the wash pipette of the washing ring in the atellica im.Check that the reagent needles are not pinching in the center of the cartridge.The ifu states in the limitations section: "this assay should not be used to diagnose or exclude acute infection.Results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings.Patient specimens may be nonreactive if collected during the early (pre-seroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Siemens healthcare diagnostics is investigating.
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Siemens filed the initial mdr 1219913-2020-00660 on december 22, 2020.January 04, 2021 additional information: the answer to the question "was this device serviced by a third party?" was received as "no".The customer provided the correct date of event as 2020-11-24.The customer reported out results from the immunochromatography test (quick test).Results were not provided.Sample type serum.Siemens healthcare diagnostics has concluded its investigation of atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with kit lots ending in 004, 005, 035 and 006.Siemens investigation determined that although non-reproducible false reactive results were observed with multiple kit lots, results indicate the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval in the ifu; therefore they are performing within claims and a change in performance has not been confirmed.The ifu states in the limitations section: "this assay should not be used to diagnose or exclude acute infection.Results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings.A reactive test result does not exclude past or present infection by other coronaviruses, such as sars cov-1, mers-cov, hku1, 229e, nl63, or oc43." a false positive/reactive result would not be used in isolation and would be correlated with clinical history.Additional laboratory testing would be used to determine specific antibody presence.The atellica im sars-cov-2 total (cov2t) lot 005 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.The investigation finding, and investigation conclusion codes were updated.
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